VYGON - V-CUTTER CATHETER TRIMMING TOOL 2FR-6FR - Vygon Corporation

Duns Number:120818216

Device Description: V-CUTTER CATHETER TRIMMING TOOL 2FR-6FR

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More Product Details

Catalog Number

AMS-850TCNS

Brand Name

VYGON

Version/Model Number

AMS-850TCNS

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)

-

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

JOK

Product Code Name

SCISSORS, MEDICAL, DISPOSABLE

Device Record Status

Public Device Record Key

19e7ba17-dbdf-4296-be97-8470447fa1ae

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Additional Identifiers

Package DI Number

30849884001151

Quantity per Package

100

Contains DI Package

10849884001157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYGON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 833