AccessGUDID - DEVICE: SIENTRA Silicone Gel Breast Implant Sizer (00819409023998)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Silicone Gel Breast Implant Sizer
Version or Model: GS10621-590MP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GS10621-590MP
Company Name: Sientra, Inc.

Primary DI Number: 00819409023998
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010209877 *Terms of Use

Device Description: Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 590 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":	Yes
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?
34178	Invasive breast implant sizer, fixed, single-use	A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRD	Sizer, Mammary, Breast Implant Volume

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200706	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: 590 cc

Device Record Status

Public Device Record Key: 16301153-4290-4c4e-a592-2f109e0764fe
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: August 02, 2021