Natrelle Inspira SoftTouch Breast Implants - Natrelle Inspira TSM 685cc Moderate profile - Allergan, Inc.

Duns Number:144796497

Device Description: Natrelle Inspira TSM 685cc Moderate profile BIOCELL textured round silicone

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More Product Details

Catalog Number

TSM-685

Brand Name

Natrelle Inspira SoftTouch Breast Implants

Version/Model Number

TSM-685

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 24, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P020056

Product Code Details

Product Code

FTR

Product Code Name

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Device Record Status

Public Device Record Key

f6f2c73b-c504-4a72-81aa-60592f5db53f

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALLERGAN, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3
3 A medical device with high risk that requires premarket approval 982
U Unclassified 702