Catalog Number

-

Brand Name

HyperGlide

Version/Model Number

104-4112

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101570

Product Code

MJN

Product Code Name

Catheter, intravascular occluding, temporary

Public Device Record Key

1fbe2db0-f340-4ee8-a5a7-3a0b2f78e636

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

August 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-