← Back to catalogue

OPUS Silicone Gel Breast Implant

FDA UDI

Class III (US FDA UDI)

by Sientra, Inc.

Identity

Trade Name
OPUS Silicone Gel Breast Implant FDA UDI
Generic Name
Silicone gel-filled breast implant, textured-surface FDA UDI
Device Name
Silicone Gel Breast Implant, Textured Shaped, Classic Base, High Projection, 320 cc FDA UDI
Model / Reference
CBASE-320HP FDA UDI
Description
Silicone Gel Breast Implant, Textured Shaped, Classic Base, High Projection, 320 cc FDA UDI

Identifiers

Catalog Number
CBASE-320HP FDA UDI
Primary DI / UDI-DI
00819409021550 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
MRI Safety
MR Safe FDA UDI

Category: Silicone gel-filled breast implant, textured-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, textured-surface.

Cleared under the same submission

P070004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sientra, Inc.

Sources (1)

  • FDA UDI 53bd2545-a7ed-46d1-a047-70bd7fcf689b 37 fields · synced May 31, 2026