AccessGUDID - DEVICE: MENTOR Smooth Round SPECTRUM (00081317002024)

GUDID

Device Identifier (DI) Information

Brand Name: MENTOR Smooth Round SPECTRUM
Version or Model: 3501480
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3501480
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317002024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Post Operatively Adjustable Saline Breast Implant, 475cc

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
Saline-filled breast implant, unstructured	A sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness.

GMDN Preferred Term Name

GMDN Definition

Saline-filled breast implant, unstructured

A sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness.

FDA Product Code

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Product Code	Product Code Name
FWM	Prosthesis, breast, inflatable, internal, saline

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990075	019

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: d822cf87-d299-487c-9517-bdf8e1f77ebf
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: September 17, 2014