Catalog Number

104-4515

Brand Name

HyperGlide

Version/Model Number

104-4515

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

K090728

Product Code

MJN

Product Code Name

Catheter, intravascular occluding, temporary

Public Device Record Key

b5b3a7d5-ecc9-4185-9fb3-217f4e671844

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

October 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-