Catalog Number

G-3898

Brand Name

Mild Chromic Gut

Version/Model Number

G-3898

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

K885018,K885018

Product Code

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Public Device Record Key

ab9d1775-4bce-4950-8ca2-7f7af367ef3e

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

20884521171470

Quantity per Package

12

Contains DI Package

10884521171473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE