Catalog Number

K5905D-S

Brand Name

DANmed

Version/Model Number

K5905D-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2022

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

-

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

HAE

Product Code Name

RONGEUR, MANUAL

Public Device Record Key

19380efb-bef7-4257-825d-6f0926bb257d

Public Version Date

August 31, 2022

Public Version Number

3

DI Record Publish Date

March 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-