Extractor, Vein
NJZ is the FDA product code for Extractor, Vein, a class I device type, regulated under 21 CFR 878.4800. FDA's definition for this code reads: "The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting. It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NJZ
- Device name
- Extractor, Vein
- FDA definition
- The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting. It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein.
- Regulation
- 21 CFR 878.4800
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this code- BR Surgical LLC
- Dr. Frigz International (Pvt) Ltd.
- FIRSTAR HEALTHCARE Company Limited (Guangzhou)
- Geister Medizintechnik GmbH
- Hive International Pvt Ltd.
- Nextcon International
- Ningbo Tianbo First Aid Product Co., Ltd.
- Schobell Industrial Ltda
- Surgicon Pvt Ltd
- Total Titanium, Inc.
- Xinhua Surgical Instrument Co. Ltd.
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