Identity
- Trade Name
- CONMED FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- UHD AUTOCLAVABLE EYECUP LAPAROSCOPE, 10 MM, 45° FDA UDI
- Model / Reference
- UHD1044 FDA UDI
- Description
- UHD AUTOCLAVABLE EYECUP LAPAROSCOPE, 10 MM, 45° FDA UDI
Identifiers
- Catalog Number
- UHD1044 FDA UDI
- Primary DI / UDI-DI
- 10845854043707 FDA UDI
- 510(k) Number
- K941541 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDIAngle — 45 degree FDA UDI
Category: Rigid optical laparoscope
Conmed by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical laparoscope.
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
Cleared under the same submission
K941541 also covers:
- 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.
- HD3 laparoscope, 5.5mm, 0°, autoclavable, HM — 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 |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI 1333166d-11ff-4596-9e39-bd32bb1ce13b 37 fields · synced Jun 1, 2026