Catalog Number

-

Brand Name

SplitStitch

Version/Model Number

HS138

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

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

08bcab53-0d42-474a-9d4f-de0f3f70ae1f

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

March 04, 2020

Package DI Number

10818614020102

Quantity per Package

12

Contains DI Package

00818614020105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-