Catalog Number

EP5512

Brand Name

Exact Medical Manufacturing

Version/Model Number

EP5512

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

-

Product Code

HMW

Product Code Name

Drape, Microscope, Ophthalmic

Public Device Record Key

2032857c-9f1a-4184-96b2-364b4dbadf87

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2017

Package DI Number

00852205007915

Quantity per Package

1

Contains DI Package

00852205007908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case