NATRELLE Saline-Filled Breast Implants - NATRELLE Style 68MP-600 Moderate Projection - Allergan, Inc.

Duns Number:144796497

Device Description: NATRELLE Style 68MP-600 Moderate Projection smooth round saline

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More Product Details

Catalog Number

68-600

Brand Name

NATRELLE Saline-Filled Breast Implants

Version/Model Number

68-600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P990074

Product Code Details

Product Code

FWM

Product Code Name

Prosthesis, Breast, Inflatable, Internal, Saline

Device Record Status

Public Device Record Key

1406fec3-c07e-4673-b70d-b329527760ed

Public Version Date

April 30, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2014

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