Catalog Number

584060

Brand Name

d.SIGN 53

Version/Model Number

584060

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 03, 2019

Issuing Agency

In HIBCC

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

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

EJS

Product Code Name

ALLOY, OTHER NOBLE METAL

Public Device Record Key

c0daa03b-ee28-4a69-a52a-ccde8e818275

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-