Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- SMALL STAPLE, 8MM, SS FDA UDI
- Model / Reference
- AR-8708 FDA UDI
- Description
- SMALL STAPLE, 8MM, SS FDA UDI
Identifiers
- Catalog Number
- AR-8708 FDA UDI
- Primary DI / UDI-DI
- 00888867044784 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Surgical staple loading unit, non-cutting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
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
MR Conditional FDA UDI
Category: Surgical staple loading unit, non-cutting
Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical staple loading unit, non-cutting.
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- arcad® — NOVASTEP · Class II
- SureForm — Intuitive Surgical, Inc. · Class II
- Tri-Staple 2.0 — Covidien LP · 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 0a64a594-afc3-4dae-9363-b52389bf5791 35 fields · synced Jun 1, 2026