Catalog Number

C0661437

Brand Name

Softcat

Version/Model Number

C0661437

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 25, 2021

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

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Public Device Record Key

f3ae9e1b-06f2-44b9-a0c2-95af72cfa67c

Public Version Date

March 29, 2021

Public Version Number

6

DI Record Publish Date

August 13, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-