Catalog Number

104-4715

Brand Name

HyperForm

Version/Model Number

104-4715

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MJN

Product Code Name

Catheter, intravascular occluding, temporary

Public Device Record Key

d6df56c7-f7c6-46c7-848f-fb393677b6de

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

October 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-