Identity
- Trade Name
- Pectoral Implant FDA UDI
- Generic Name
- Pectoral implant FDA UDI
- Device Name
- Pectoral Style 4 Size 1 Left FDA UDI
- Model / Reference
- E FDA UDI
- Description
- Pectoral Style 4 Size 1 Left FDA UDI
Identifiers
- Catalog Number
- 500-401-5 FDA UDI
- Primary DI / UDI-DI
- B4905004015 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Pectoral implant
Pectoral Implant by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pectoral implant.
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- PowerFlex™ Pectoral Implant Sizer — Implantech Associates, Inc. · Class II
- PowerFlex™ Pectoral Implant Sizer — Implantech Associates, Inc. · Class II
- Powerflex™ Pectoral Implant, Smooth (Novack Style 3) — Implantech Associates, Inc. · Class II
- Powerflex™ Pectoral Implant, Smooth (Aiache Style 4) — Implantech Associates, Inc. · Class II
- Powerflex™ Pectoral Implant, Aiache Style 1, SDM — Implantech Associates, Inc. · Class II
- PowerFlex™ Pectoral Implant Sizer — Implantech Associates, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
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 86879856-fd10-40e3-8583-29dc788b45f9 36 fields · synced Jun 1, 2026