VISIGLIDE - VISIGLIDE Single Use Guidewire - TERUMO CORPORATION

Duns Number:690543319

Device Description: VISIGLIDE Single Use Guidewire

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More Product Details

Catalog Number

G-240-3527S

Brand Name

VISIGLIDE

Version/Model Number

G-240-3527S

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

OCY

Product Code Name

Endoscopic guidewire, gastroenterology-urology

Device Record Status

Public Device Record Key

7ac95e1b-d8e5-491f-8b8d-da49b73a599f

Public Version Date

July 14, 2022

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

54953170282824

Quantity per Package

5

Contains DI Package

04953170282829

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