Catalog Number

-

Brand Name

N/A

Version/Model Number

1416030

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

K964484

Product Code

KHJ

Product Code Name

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

Public Device Record Key

6efe1413-ec6d-4f95-95e0-fc7a0c4c3d11

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

May 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-