Identity
- Trade Name
- AART Pectoralis Implant Sizer FDA UDI
- Generic Name
- Pectoral implant FDA UDI
- Device Name
- Szr - Pectoral Sty 1 Sz 4 R NS FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Szr - Pectoral Sty 1 Sz 4 R NS FDA UDI
Identifiers
- Catalog Number
- 500-104-6-2A FDA UDI
- Primary DI / UDI-DI
- B49050010462A0 FDA UDI
- 510(k) Number
- K021337 FDA UDI
- FDA Product Code
- MIC FDA UDI
- GMDN Term
- Pectoral implant 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 Pectoralis Implant Sizer by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 94595632-7d67-4ca0-ad9d-e57451cdf635 37 fields · synced May 30, 2026