Identity
- Trade Name
- AART Calf Implant Sizer FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Szr - Calf Sty 1 Sz 1 NS FDA UDI
- Model / Reference
- C FDA UDI
- Description
- Szr - Calf Sty 1 Sz 1 NS FDA UDI
Identifiers
- Catalog Number
- 502-101-2C FDA UDI
- Primary DI / UDI-DI
- B4905021012C0 FDA UDI
- 510(k) Number
- K022511 FDA UDI
- FDA Product Code
- MIB FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
The AART Calf Implant Sizer is a non-sterile, solid silicone elastomer device designed for tissue reconstruction and plastic surgery. It is typically available in a cube or rectangular cross-section, carved or trimmed to fit various patient anatomy, and used for soft-tissue augmentation or prosthetic implant formation.
Cleared under the same submission
K022511 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 748fa539-ce92-4a04-a423-9760c20060ab 37 fields · synced Jun 20, 2026