Identity
- Trade Name
- CONMED FDA UDI
- Generic Name
- Ear lobe perforator FDA UDI
- Device Name
- LAPAROSCOPE 5.5MM 30 DEGREE FDA UDI
- Model / Reference
- 8090-02 FDA UDI
- Description
- LAPAROSCOPE 5.5MM 30 DEGREE FDA UDI
Identifiers
- Catalog Number
- 8090-02 FDA UDI
- Primary DI / UDI-DI
- 20845854024840 FDA UDI
- 510(k) Number
- K941541 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Ear lobe perforator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Conmed by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K941541 also covers:
- CONMED — Conmed Corporation
- CONMED — Conmed Corporation
- CONMED — Conmed Corporation
- CONMED — Conmed Corporation
- CONMED — Conmed Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- HD Laparoscope, 3, 3mm, 0°, autoclavable — Medica Corp.
- HD Laparoscope, 3, 3mm, 30°, autoclavable — Medica Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI c76286e4-7c98-4cb1-9061-27cfaf879521 37 fields · synced Jun 1, 2026