Identity
- Trade Name
- OPUS Silicone Gel Breast Implant FDA UDI
- Generic Name
- Silicone gel-filled breast implant, smooth-surface FDA UDI
- Device Name
- Silicone Gel Breast Implant, Smooth Round, Xtra High Projection, 245 cc FDA UDI
- Model / Reference
- 10621-245XP FDA UDI
- Description
- Silicone Gel Breast Implant, Smooth Round, Xtra High Projection, 245 cc FDA UDI
Identifiers
- Catalog Number
- 10621-245XP FDA UDI
- Primary DI / UDI-DI
- 00819409022014 FDA UDI
- PMA Number
- P070004 FDA UDI
- FDA Product Code
- FTR FDA UDI
- GMDN Term
- Silicone gel-filled breast implant, smooth-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, smooth-surface
OPUS Silicone Gel Breast Implant 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, smooth-surface.
- NATRELLE Silicone-Filled Breast Implants — Allergan · Class III
- Natrelle Inspira Cohesive Breast Implants — Allergan · Class III
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
- MENTOR MemoryGel BOOST Breast Implant — Mentor Texas LP · Class III
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A. · Class III
- Natrelle Inspira Cohesive Breast Implants — Allergan · Class III
- MENTOR MemoryGel Xtra Breast Implant — Mentor Texas LP · Class III
- Natrelle Inspira Cohesive Breast Implants — Allergan · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sientra, Inc.
Sources (1)
- FDA UDI fcb5985b-3e5a-44e9-a0ee-43ed6de70c97 37 fields · synced Jun 1, 2026