Catalog Number

H7492354800160

Brand Name

Rotaglide™

Version/Model Number

H7492354800160

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

P900056,P900056

Product Code

MCX

Product Code Name

CATHETER, CORONARY, ATHERECTOMY

Public Device Record Key

aac21594-6cd7-40d1-9556-9abe4f2a950e

Public Version Date

April 06, 2021

Public Version Number

5

DI Record Publish Date

January 21, 2015

Package DI Number

08714729837619

Quantity per Package

6

Contains DI Package

08714729855507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-