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-850TC

Brand Name

VYGON

Version/Model Number

AMS-850TC

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

bcf60dc4-1fc7-4bdc-b392-ad7d9f2673dd

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

50849884002107

Quantity per Package

360

Contains DI Package

30849884002103

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