Catalog Number

-

Brand Name

Plain Gut

Version/Model Number

CSN11170V

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

K142656,K142656

Product Code

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Public Device Record Key

14d3ec50-a07b-496c-a622-04bf053a1135

Public Version Date

January 28, 2022

Public Version Number

5

DI Record Publish Date

October 11, 2017

Package DI Number

20884521548326

Quantity per Package

24

Contains DI Package

10884521548329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK