Catalog Number

-

Brand Name

N/A

Version/Model Number

1532505

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

822b11f1-bfd2-4fa7-a740-0a0c03a9f009

Public Version Date

July 07, 2020

Public Version Number

1

DI Record Publish Date

June 29, 2020

Package DI Number

20763000040226

Quantity per Package

10

Contains DI Package

00763000040222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK