Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- 4K Laparoscope, 45°, 10x333mm, NIR50540 FDA UDI
- Model / Reference
- AR-3351-1046 FDA UDI
- Description
- 4K Laparoscope, 45°, 10x333mm, NIR50540 FDA UDI
Identifiers
- Catalog Number
- AR-3351-1046 FDA UDI
- Primary DI / UDI-DI
- 00888867161139 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
Category: Rigid optical laparoscope
Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid optical laparoscope.
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- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- CONMED — Conmed Corporation · Class II
- ELMED — ELMED INCORPORATED · Class II
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
- Arthrex, Inc.
Sources (1)
- FDA UDI 0b6edf9e-5913-4c4e-a0c9-2ffc5f1a7dcd 35 fields · synced May 30, 2026