Catalog Number

-

Brand Name

Puragraft

Version/Model Number

PGT594B

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

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Public Device Record Key

f8eee3c0-a832-4b6a-82c4-38c801804fe7

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

February 18, 2019

Package DI Number

10848782033185

Quantity per Package

12

Contains DI Package

00848782033188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box