AccessGUDID - DEVICE: SIENTRA Pectoral Implant (00812790023172)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Pectoral Implant
Version or Model: 20132-160EU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20132-160EU
Company Name: Sientra, Inc.

Primary DI Number: 00812790023172
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: Pectoral Implant, Silicone Elastomer, Textured, Left, 230 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?
48163	Pectoral implant	An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIB	Elastomer, Silicone Block

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042054	000

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: 230 cc

Device Record Status

Public Device Record Key: f726cc89-404a-4f80-83d4-d0edf98cf4a1
Public Version Date: October 25, 2023
Public Version Number: 7
DI Record Publish Date: October 23, 2015