Catalog Number

E5918

Brand Name

Exact Medical Manufacturing

Version/Model Number

E5918

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,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

0f87c275-2b59-4ed5-85af-144821dceed6

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

November 13, 2016

Package DI Number

00850024023017

Quantity per Package

20

Contains DI Package

00816953027403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case