Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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)

Yes

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

K882724,K882724,K882724

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

99e1c484-0a7b-4924-9235-77b9dab3cfee

Public Version Date

February 19, 2019

Public Version Number

4

DI Record Publish Date

January 27, 2017

Package DI Number

50748426120951

Quantity per Package

2

Contains DI Package

30748426120957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-