Catalog Number

HSK-98980

Brand Name

Hexa

Version/Model Number

HSK-98980

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

GAP

Product Code Name

SUTURE, NONABSORBABLE, SILK

Public Device Record Key

1f266830-b24a-4396-a454-f07161afc903

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2020

Package DI Number

10850023750034

Quantity per Package

12

Contains DI Package

00850023750037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK