Catalog Number

G0994882

Brand Name

Securex

Version/Model Number

G0994882

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

3dd36705-2fb7-4896-8b16-68f9fbc521c3

Public Version Date

April 06, 2021

Public Version Number

8

DI Record Publish Date

August 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-