Identity
- Trade Name
- Silicone Gel Sizer FDA UDI
- Generic Name
- Silicone gel-filled breast implant, textured-surface FDA UDI
- Device Name
- Silicone Gel Sizer, Smooth Shaped, Classic Base, Moderate Projection, 550 cc FDA UDI
- Model / Reference
- GSCBASE-550MP FDA UDI
- Description
- Silicone Gel Sizer, Smooth Shaped, Classic Base, Moderate Projection, 550 cc FDA UDI
Identifiers
- Catalog Number
- GSCBASE-550MP FDA UDI
- Primary DI / UDI-DI
- 00819409024643 FDA UDI
- PMA Number
- P070004 FDA UDI
- FDA Product Code
- FTR FDA UDI
- GMDN Term
- Silicone gel-filled breast implant, textured-surface FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.3540 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
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Silicone gel-filled breast implant, textured-surface
Silicone Gel Sizer by Sientra, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone gel-filled breast implant, textured-surface.
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryShape Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryShape Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryShape Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
Cleared under the same submission
P070004 also covers:
- OPUS Silicone Gel Breast Implant — Sientra, Inc.
- OPUS Silicone Gel Breast Implant — Sientra, Inc.
- OPUS Silicone Gel Breast Implant — Sientra, Inc.
- OPUS Silicone Gel Breast Implant — Sientra, Inc.
- OPUS Silicone Gel Breast Implant — Sientra, Inc.
- OPUS Silicone Gel Breast Implant — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Sientra, Inc.
Sources (1)
- FDA UDI 178e283c-de77-40bb-93b8-0849449e3396 37 fields · synced Jun 8, 2026