Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- Spine Endoscope Depth Stop, 6.3mm FDA UDI
- Model / Reference
- AR-S3350-063-DS FDA UDI
- Description
- Spine Endoscope Depth Stop, 6.3mm FDA UDI
Identifiers
- Catalog Number
- AR-S3350-063-DS FDA UDI
- Primary DI / UDI-DI
- 00888867499386 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal endoscopic-access system
Arthrex® by Arthrex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal endoscopic-access system.
- joimax® — JOIMAX, INC. · Class II
- Kerrison — ELLIQUENCE LLC · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- OptiLIF Endo, Direct Visualization System — SPINEOLOGY INC. · Class I
- MaxView™ System - Posterior Set — VISEON, INC. · Class II
- Trephine — ELLIQUENCE LLC · Class I
- Kerrison — ELLIQUENCE LLC · Class I
- Medfix — Medfix International, LLC · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arthrex, Inc.
Sources (1)
- FDA UDI 74baab75-e8b5-49ef-9dd4-9135219de5c2 35 fields · synced May 30, 2026