AccessGUDID - DEVICE: MENTOR MemoryGel Resterilizable Gel Sizer (00081317007852)

GUDID

Device Identifier (DI) Information

Brand Name: MENTOR MemoryGel Resterilizable Gel Sizer
Version or Model: RSZ5504S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSZ-5504S
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317007852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: High Profile, HP 550cc 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 [?]
K062421	000

Sterilization

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

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Customer Contact

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DEVICE: MENTOR MemoryGel Resterilizable Gel Sizer (00081317007852)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact