Catalog Number

-

Brand Name

N/A

Version/Model Number

1532510

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

KHJ

Product Code Name

POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)

Public Device Record Key

0d872121-bda8-4a13-abe4-263b32fbf461

Public Version Date

July 07, 2020

Public Version Number

1

DI Record Publish Date

June 29, 2020

Package DI Number

20763000040233

Quantity per Package

10

Contains DI Package

00763000040239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK