Identity
- Trade Name
- Anchor Curved Tip Kerrison Rongeur FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Model / Reference
- PSZ-400-201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00685447002024 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Anchor Curved Tip Kerrison Rongeur by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Baylis Médicale Cie Inc
Sources (1)
- FDA UDI 530565a8-ce17-413a-93da-d37f8a7766bb 34 fields · synced May 30, 2026