Identity
- Trade Name
- AART Calf Implant Sizer FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Szr - Calf Sty 3 Sz 9 NS FDA UDI
- Model / Reference
- E FDA UDI
- Description
- Szr - Calf Sty 3 Sz 9 NS FDA UDI
Identifiers
- Catalog Number
- 502-309-2E FDA UDI
- Primary DI / UDI-DI
- B4905023092E0 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
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 Calf Implant Sizer by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8a90ccd4-c44d-4c7d-a64d-98a2212f6d67 37 fields · synced Jun 1, 2026