AccessGUDID - DEVICE: Natrelle Inspira SoftTouch Breast Implants (10888628033993)

GUDID

Device Identifier (DI) Information

Brand Name: Natrelle Inspira SoftTouch Breast Implants
Version or Model: TSM-520
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TSM-520
Company Name: Allergan, Inc.

Primary DI Number: 10888628033993
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: Natrelle Inspira TSM 520cc Moderate profile BIOCELL |textured|round|silicone

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:	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?
64082	Silicone gel-filled breast implant, textured-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is textured. The implant may vary in shape, profile, volume and shell thickness.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020056	036

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: 520 cc

Device Record Status

Public Device Record Key: 43339b1a-51a9-49e5-b72e-37cfe35ba69d
Public Version Date: October 14, 2021
Public Version Number: 4
DI Record Publish Date: January 13, 2017