Catalog Number

E2008

Brand Name

E2008 Drape, 145x90cm, Fenestration 12x6cm, Absorbent PE

Version/Model Number

E2008

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

54f3c92a-1162-477d-8612-92887a580e1a

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

October 07, 2016

Package DI Number

00816953020398

Quantity per Package

25

Contains DI Package

00816953020381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case