Catalog Number

C2090172

Brand Name

Premilene

Version/Model Number

C2090172

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 22, 2015

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

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

-

Product Code

GAW

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Public Device Record Key

846f2f02-bee8-48a7-9ed0-34aec9fa2a7f

Public Version Date

March 29, 2021

Public Version Number

7

DI Record Publish Date

August 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-