Identity
- Trade Name
- Gluteal Implant FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Gluteal Style 1 Size 6, Smooth FDA UDI
- Model / Reference
- D FDA UDI
- Description
- Gluteal Style 1 Size 6, Smooth FDA UDI
Identifiers
- Catalog Number
- 501-106-3 FDA UDI
- Primary DI / UDI-DI
- B4905011063 FDA UDI
- 510(k) Number
- K021839 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
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: Silicone-block tissue reconstructive material
Gluteal Implant by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-block tissue reconstructive material.
- SG Gluteal Implant — Implantech Associates, Inc. · Class II
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- Powerflex™ Pectoral Implant — Implantech Associates, Inc. · Class II
- SG Pec Sizer — Implantech Associates, Inc. · Class II
- SG Pec Implant Style 4 — Implantech Associates, Inc. · Class II
- Rectangular Carving Block 2.0 — Implantech Associates, Inc. · Class II
Cleared under the same submission
K021839 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 d6edd5bd-fed9-4256-b80f-2bf5d2813603 36 fields · synced May 30, 2026