Catalog Number

E6828

Brand Name

Exact Medical

Version/Model Number

E6828

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101689,K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

5961ad2d-3a73-4c30-aa0e-09048ce01306

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

00850024023130

Quantity per Package

50

Contains DI Package

00850024023123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER CASE