SEJUnclassified
Wound Dressings Containing Topical Analgesics
Unknown
SEJ is the FDA product code for Wound Dressings Containing Topical Analgesics. FDA's definition for this code reads: "A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SEJ
- Device name
- Wound Dressings Containing Topical Analgesics
- FDA definition
- A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code SEJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2009 | 1 |
Applicants with the most clearances
Product code SEJ| Applicant | Clearances |
|---|---|
| Amerx Health Care Corp. | 1 |
| At Squared, LLC | 1 |
| Johnson & Johnson Consumer Companies, Inc. | 1 |
| Mckinley-Ross Laboratories, Inc. | 1 |
| Micro-Coll | 1 |
| MPM Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.