Gentell
Bristol, PA, US
GENTELL appears in FDA device records in Bristol, PA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Gentell in 1999.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2530957 | 1000522686 | GENTELL | 180 Rittenhouse Circle, Bristol, PA 19007 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EZSAppliance, Colostomy, Disposable
- EXHBag, Urinary, Ileostomy
- EXGBag, Urine Collecting, Ureterostomy
- FQMBandage, Elastic
- EZRCement, Stomal Appliance, Ostomy
- EXBCollector, Ostomy
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- NABGauze / Sponge,Nonresorbable For External Use
- EZQPouch, Colostomy
- EXEProtector, Ostomy
- FMPProtector, Skin Pressure
- KGXTape And Bandage, Adhesive
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1910-2020 | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1909-2020 | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1908-2020 | Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1907-2020 | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1626-2020 | Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1625-2020 | Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1624-2020 | Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified | |
| Z-1623-2020 | Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain