GLIDECATH - RADIFOCUS GLIDECATH - TERUMO CORPORATION

Duns Number:690543319

Device Description: RADIFOCUS GLIDECATH

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More Product Details

Catalog Number

RF*YE25110A

Brand Name

GLIDECATH

Version/Model Number

CG515

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

452026fc-c01a-4b75-b033-3c136ca77882

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

34987350772610

Quantity per Package

5

Contains DI Package

04987350772619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox

"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