Catalog Number

EP54-120

Brand Name

Exact Memdical Manufacturing

Version/Model Number

EP54-120

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

9c622bb2-1d13-4ffe-a636-b8e963fa4b0f

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Package DI Number

20852205007964

Quantity per Package

1

Contains DI Package

10852205007967

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case