Catalog Number

BO-13821-B

Brand Name

Critical Cover

Version/Model Number

BO-13821-B

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYF

Product Code Name

Cap, Surgical

Public Device Record Key

3cc2a3ba-7e14-4bee-986c-9575e9c27106

Public Version Date

August 16, 2018

Public Version Number

1

DI Record Publish Date

July 16, 2018

Package DI Number

20817583020653

Quantity per Package

10

Contains DI Package

10817583020656

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case