Identity
- Trade Name
- Lesinski FDA UDI
- Generic Name
- Ossicular prosthesis, partial FDA UDI
- Device Name
- PROSTHESIS 0437 LESINSKI MOD LOOP 4.25MM FDA UDI
- Model / Reference
- 0437 FDA UDI
- Description
- PROSTHESIS 0437 LESINSKI MOD LOOP 4.25MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681490023436 FDA UDI
- 510(k) Number
- K823429 FDA UDI
- FDA Product Code
- LTB FDA UDI
- GMDN Term
- Ossicular prosthesis, partial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1235 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
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
- Length — 4.25 Millimeter FDA UDI
Lesinski by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K823429 also covers:
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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 579cf26b-e0fd-4974-9068-9e856a0b8994 37 fields · synced Jun 8, 2026