Identity
- Trade Name
- AART Malar Implant Sizer FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Szr - Malar Sty 1 Sz 2 L NS FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Szr - Malar Sty 1 Sz 2 L NS FDA UDI
Identifiers
- Catalog Number
- 401-102-5-2A FDA UDI
- Primary DI / UDI-DI
- B49040110252A0 FDA UDI
- 510(k) Number
- K021419 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
No
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
Dry Heat Sterilization FDA UDI
AART Malar Implant Sizer by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K021419 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
- Aart
Sources (1)
- FDA UDI d12fc44b-0ab8-4aec-89ab-64e732dd8b6d 37 fields · synced Jun 8, 2026