Catalog Number

21-0045A

Brand Name

Best Seal

Version/Model Number

21-0045A

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

32a9193b-a12a-4bbf-a40a-ece015c680bd

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

869319000251

Quantity per Package

8

Contains DI Package

00869319000244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case