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SIENTRA Silicone Gel Breast Implant

FDA UDI

Class III (US FDA UDI)

by Sientra, Inc.

Identity

Trade Name
SIENTRA 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 Oval Base, Moderate Profile, 250 cc FDA UDI
Model / Reference
20645-250MP FDA UDI
Description
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 250 cc FDA UDI

Identifiers

Catalog Number
20645-250MP FDA UDI
Primary DI / UDI-DI
00812790021772 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
Not 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

A comprehensive and accurate guide to the Sientra Silicone Gel Breast Implant, a single-use device designed for breast augmentation. Learn about its features, compliance, and usage instructions.

Cleared under the same submission

P070004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sientra, Inc.

Sources (1)

  • FDA UDI 59e73e81-c6a7-4841-ae78-16e3d5501ea5 38 fields · synced Jul 27, 2026