AccessGUDID - DEVICE: MENTOR Tissue Expander (00081317002437)

GUDID

Device Identifier (DI) Information

Brand Name: MENTOR Tissue Expander
Version or Model: 3504307M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3504307M
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317002437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Smooth Round, 550cc

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

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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
Tissue expander	An sterile inflatable device intended to be temporarily implanted to enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of a long-term implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube, and an inflation valve, and is managed by a healthcare professional. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Tissue expander

An sterile inflatable device intended to be temporarily implanted to enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of a long-term implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube, and an inflation valve, and is managed by a healthcare professional. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
LCJ	EXPANDER, SKIN, INFLATABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K842883	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 477219a1-4e5e-404d-8795-9f7eee3819a9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2015