Catalog Number

PGTPE1

Brand Name

REGENX PuraKOTE

Version/Model Number

PGTPE1

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

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

0d537c15-58ba-4519-9aff-04a1b1a3bc41

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

December 15, 2016

Package DI Number

10614950008725

Quantity per Package

10

Contains DI Package

00614950008728

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box