Catalog Number

-

Brand Name

EOS

Version/Model Number

EosSmear

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

K963685

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

36ae56f7-8992-463b-b4ae-ed357ead4b8d

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-