Catalog Number

582047

Brand Name

IS 64

Version/Model Number

582047

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

43dbb91d-f176-4c94-aafe-c69d1a379eaa

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

October 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-