AccessGUDID - DEVICE: MENTOR MemoryShape MM Resterilizable Gel Sizer (00081317008408)

GUDID

Device Identifier (DI) Information

Brand Name: MENTOR MemoryShape MM Resterilizable Gel Sizer
Version or Model: RSZ1108S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSZ-1108S
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317008408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Medium Height, Moderate Profile Sterile, MM 215cc Gel Sizer

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58856	Invasive breast implant sizer, fixed, reusable	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 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.	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 [?]
K151055	000

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: 1ff4aa7b-af21-4481-bba1-3d6f8d769d47
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: November 03, 2017