Identity
- Trade Name
- K-Piston Titanium FDA UDI
- Generic Name
- Ossicular prosthesis, partial FDA UDI
- Device Name
- Ossicular Prosthesis, partial FDA UDI
- Model / Reference
- 1006106 FDA UDI
- Description
- Ossicular Prosthesis, partial FDA UDI
Identifiers
- Catalog Number
- 1006106 FDA UDI
- Primary DI / UDI-DI
- EHKM10061061 FDA UDI
- 510(k) Number
- K002221 FDA UDI
- FDA Product Code
- ETB FDA UDI
- GMDN Term
- Ossicular prosthesis, partial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3450 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Ossicular prosthesis, partial
K-Piston Titanium by Heinz Kurz — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ossicular prosthesis, partial.
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Cleared under the same submission
K002221 also covers:
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
- K-Piston Titanium — Heinz Kurz
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
- Heinz Kurz
Sources (1)
- FDA UDI be67d8e9-f19d-426f-9e2f-38e6b5bf2c21 36 fields · synced May 30, 2026