AccessGUDID - DEVICE: SIENTRA Silicone Gel Breast Implant (00812790023592)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Silicone Gel Breast Implant
Version or Model: 20646-390MP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20646-390MP
Company Name: Sientra, Inc.

Primary DI Number: 00812790023592
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 010209877 *Terms of Use

Device Description: Silicone Gel Breast Implant, Textured Shaped Round Base, Moderate Profile, 390 cc

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64082	Silicone gel-filled breast implant, textured-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is textured. The implant may vary in shape, profile, volume and shell thickness.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P070004	008

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Volume: 390 cc

Device Record Status

Public Device Record Key: 15f8a6b4-fa6b-4c98-8ec5-31588080e138
Public Version Date: October 25, 2023
Public Version Number: 5
DI Record Publish Date: August 24, 2017