AccessGUDID - DEVICE: MENTOR Round High Profile Single Use Saline Breast Implant Sizer (00081317002888)

GUDID

Device Identifier (DI) Information

Brand Name: MENTOR Round High Profile Single Use Saline Breast Implant Sizer
Version or Model: 351-3190SZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 351-3190SZ
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317002888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Round High Profile Saline Breast Implant Sizer, 190cc

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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 [?]
K010709	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
No Device Sizes

Device Record Status

Public Device Record Key: 1a30ea9b-bc20-4df4-87fd-e68cfb5712a1
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: May 16, 2016