Identity
- Trade Name
- AART Malar Implant FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Malar Sty 1 Sz 1 L Sterile FDA UDI
- Model / Reference
- B FDA UDI
- Description
- Malar Sty 1 Sz 1 L Sterile FDA UDI
Identifiers
- Catalog Number
- 401-101-5B FDA UDI
- Primary DI / UDI-DI
- B4904011015B0 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 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 03a1aca1-c5fe-40a2-99e3-3c0859def1fd 37 fields · synced Jun 1, 2026