Identity
- Trade Name
- First MPJ Sizer Template LG FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- First MPJ Sizer Template LG FDA UDI
- Model / Reference
- 22994 FDA UDI
- Description
- First MPJ Sizer Template LG FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20922994 FDA UDI
- 510(k) Number
- K041595 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
First MPJ Sizer Template LG by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K041595 also covers:
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- FIRST MPJ HEMI COMPLETE KIT — BIOPRO, INC.
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- Impactor Tip LG — BIOPRO, INC.
- LESSER MPJ TRIAL 10.25MM — BIOPRO, INC.
- LESSER MPJ TRIAL 11.0MM — BIOPRO, INC.
- LESSER MPJ TRIAL 14.00MM — BIOPRO, INC.
- MPJ TRIAL 17mm (SM) — BIOPRO, INC.
- MPJ TRIAL 20mm (MD) — BIOPRO, INC.
- MPJ TRIAL 21.5mm (ML) — BIOPRO, INC.
- MPJ Trial 21.5mm (ML) — BIOPRO, INC.
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 |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 3a9258d2-d918-448e-b602-427efc38e833 35 fields · synced Jun 8, 2026