Identity
- Trade Name
- iUni® iPoly™ Insert Kit FDA UDI
- Generic Name
- Uncoated unicondylar knee femur prosthesis FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- RUK010130001 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- RUK0101300 FDA UDI
- Primary DI / UDI-DI
- M572RUK0101300011 FDA UDI
- FDA Product Code
- HSX FDA UDIOOG FDA UDI
- GMDN Term
- Uncoated unicondylar knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 FDA UDI888.3560 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 13 Millimeter FDA UDI
iUni® iPoly™ Insert Kit by Conformis, 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
- Conformis, Inc.
Sources (1)
- FDA UDI 1e96b98a-7fa4-4e05-954a-b53b2b3efe0a 37 fields · synced May 31, 2026