Catalog Number

-

Brand Name

TroClose1200™

Version/Model Number

GSTC1200

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171494,K171494,K171494

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

166acd77-b5cd-492d-bf00-f3d697b905db

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2017

Package DI Number

17290017191000

Quantity per Package

6

Contains DI Package

07290017191003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-