Catalog Number

-

Brand Name

KIMGUARD™ KC400 Sterilization Wrap

Version/Model Number

68248

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

52f1c86c-bb26-4220-9339-f0da7c108e6f

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

November 30, 2016

Package DI Number

10036000682486

Quantity per Package

10

Contains DI Package

00036000682489

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case