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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 Round Base, Moderate Profile, 360 cc FDA UDI
Model / Reference
20646-360MP FDA UDI
Description
Silicone Gel Breast Implant, Textured Shaped Round Base, Moderate Profile, 360 cc FDA UDI

Identifiers

Catalog Number
20646-360MP FDA UDI
Primary DI / UDI-DI
00812790023585 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

SIENTRA Silicone Gel Breast Implant by Sientra, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 1eabc783-9eb7-47bf-b172-9d5fbec55928 38 fields · synced May 30, 2026