AccessGUDID - DEVICE: NATRELLE Saline-Filled Breast Implants (10888628000711)

GUDID

Device Identifier (DI) Information

Brand Name: NATRELLE Saline-Filled Breast Implants
Version or Model: 163-440
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 163-440
Company Name: Allergan, Inc.

Primary DI Number: 10888628000711
Issuing Agency: GS1
Commercial Distribution End Date: July 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 144796497 *Terms of Use

Device Description: STYLE 163 440CC Full Projection BIOCELL |textured|contour|saline

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64084	Saline-filled breast implant, unstructured, textured-surface	An 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 shell surface is textured. 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 and shell thickness.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FWM	Prosthesis, Breast, Inflatable, Internal, Saline

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990074	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 440 cc

Device Record Status

Public Device Record Key: 4ed6f8aa-8c58-44b3-ac3b-08fb0f665cca
Public Version Date: October 13, 2021
Public Version Number: 5
DI Record Publish Date: September 17, 2014