Identity
- Trade Name
- SIENTRA Malar Implant FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 50 mm FDA UDI
- Model / Reference
- 25-50DU FDA UDI
- Description
- Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 50 mm FDA UDI
Identifiers
- Catalog Number
- 25-50DU FDA UDI
- Primary DI / UDI-DI
- 00812790023318 FDA UDI
- 510(k) Number
- K981835 FDA UDI
- FDA Product Code
- LZK FDA UDI
- GMDN Term
- Malar prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDI
SIENTRA Malar Implant by Sientra, 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
- Sientra, Inc.
Sources (1)
- FDA UDI dd45e566-9e01-47bc-bf31-da5159c591b4 38 fields · synced May 30, 2026