Catalog Number

-

Brand Name

EOS

Version/Model Number

EosSpec IV-DILATOR 7-8MM

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

-

Product Code

HDQ

Product Code Name

Dilator, Cervical, Fixed Size

Public Device Record Key

dee8c730-1990-420a-a892-9705d93c0dd8

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

-