Catalog Number

-

Brand Name

MICROSUTURE

Version/Model Number

GEM189BK

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

eb3ae4cc-62e4-4c93-a367-65f77d54e1b5

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 02, 2020

Package DI Number

10810020084105

Quantity per Package

12

Contains DI Package

00810020084108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-