Catalog Number

EP54-150

Brand Name

Exact Medical Manufacturing

Version/Model Number

EP54-150

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)

Yes

Over the Counter (OTC)

-

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

c9abb60f-be38-42bd-8418-69a427963c3a

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Package DI Number

20852205007971

Quantity per Package

1

Contains DI Package

10852205007974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case