Identity
- Trade Name
- UHR FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Device Name
- Bipolar Component FDA UDI
- Model / Reference
- UH1-48-32 FDA UDI
- Description
- Bipolar Component FDA UDI
Identifiers
- Catalog Number
- UH1-48-32 FDA UDI
- Primary DI / UDI-DI
- 07613327017021 FDA UDI
- FDA Product Code
- KWL FDA UDI
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 48.0 Millimeter FDA UDILumen/Inner Diameter — 32.0 Millimeter FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplasty
Uhr by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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K222632 also covers:
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
K800207 also covers:
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
- UHR — Howmedica Osteonics Corp.
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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 1a6b7687-81f2-43a6-9755-92c8d2f9707b 36 fields · synced May 30, 2026