Catalog Number

907780

Brand Name

8MM CANNULATED DILATOR

Version/Model Number

907780

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"

-

For Single-Use

-

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

HWR

Product Code Name

DRIVER, PROSTHESIS

Public Device Record Key

2d186f37-b0e4-46b9-9bd7-f9f8730f1d22

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-