AccessGUDID - DEVICE: MENTOR MemoryShape LM Plus Resterilizable Gel Sizer (00081317008859)

GUDID

Device Identifier (DI) Information

Brand Name: MENTOR MemoryShape LM Plus Resterilizable Gel Sizer
Version or Model: RSZ1357S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSZ1357S
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317008859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Low Height, Moderate Plus Profile Sterile, 415cc

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":	Yes
For Single-Use:	No
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Invasive breast implant sizer, reusable	A sterile surgical instrument 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 is typically composed of a silicone rubber shell with a single lumen, filled 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 reusable device intended to be resterilized between patient applications.

GMDN Preferred Term Name

GMDN Definition

Invasive breast implant sizer, reusable

A sterile surgical instrument 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 is typically composed of a silicone rubber shell with a single lumen, filled 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 reusable device intended to be resterilized between patient applications.

FDA Product Code

[?]

Product Code	Product Code Name
MRD	SIZER, MAMMARY, BREAST IMPLANT VOLUME

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 40ea7fe0-e9d8-49f5-adb5-2a643736da92
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 03, 2017