Identity
- Trade Name
- Arthrex FDA UDI
- Generic Name
- Suturing unit, reprocessed FDA UDI
- Model / Reference
- AR-16992N FDA UDI
Identifiers
- Primary DI / UDI-DI
- B504SRAR16992N0 FDA UDI
- FDA Product Code
- LHX FDA UDI
- GMDN Term
- Suturing unit, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suturing unit, reprocessed
Arthrex by Provision — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Provision
Sources (1)
- FDA UDI 5a3b42e1-6b75-4380-a8f0-c378a7d304cf 32 fields · synced Jun 6, 2026