Catalog Number

-

Brand Name

HS SUTURE TAPE

Version/Model Number

HS210

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

-

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

3887af53-4a62-4718-b21f-9579557064d4

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

July 19, 2017

Package DI Number

10812444026747

Quantity per Package

6

Contains DI Package

00812444026740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-