Identity
- Trade Name
- Penenberg's acetabular reamer Ø56 FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- Acetabular reamer for hip arthroplasty FDA UDI
- Model / Reference
- T10935 FDA UDI
- Description
- Acetabular reamer for hip arthroplasty FDA UDI
Identifiers
- Catalog Number
- T10935 FDA UDI
- Primary DI / UDI-DI
- 07640187916768 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Acetabular orthopaedic reamer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
Penenberg's acetabular reamer Ø56 by MPS Micro Precision Systems AG — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
Sources (1)
- FDA UDI 0a11974c-ac5c-4bb2-9ad9-56ba7a1bda78 36 fields · synced May 30, 2026