HEARTRAIL - HEARTRAIL III Guiding Catheter - TERUMO CORPORATION

Duns Number:690543319

Device Description: HEARTRAIL III Guiding Catheter

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More Product Details

Catalog Number

GC-U5IR201N

Brand Name

HEARTRAIL

Version/Model Number

40-5482

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

3bac9b29-bc48-40a3-b3e9-5c5d35a085e5

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

54987350866597

Quantity per Package

5

Contains DI Package

04987350866592

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"TERUMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 364
3 A medical device with high risk that requires premarket approval 29