Catalog Number

-

Brand Name

Plain Gut

Version/Model Number

SG-822

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

56429dcd-6c89-4477-bdb4-d46e1d3a1a39

Public Version Date

January 28, 2022

Public Version Number

5

DI Record Publish Date

September 02, 2015

Package DI Number

20884521056081

Quantity per Package

36

Contains DI Package

10884521056084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE