Catalog Number

-

Brand Name

OPTIME®

Version/Model Number

18B35B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K062366,K062366

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

ff6f1093-d682-4b33-a44e-d8c7c1302cce

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

January 09, 2020

Package DI Number

13661522040901

Quantity per Package

36

Contains DI Package

03661522040904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-