VIA Microcatheter - VIA 27 Microcatheter - SEQUENT MEDICAL, INC.

Duns Number:796807340

Device Description: VIA 27 Microcatheter

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More Product Details

Catalog Number

FG27154-01

Brand Name

VIA Microcatheter

Version/Model Number

VIA-27-154-01

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"

Yes

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

KRA

Product Code Name

Catheter, Continuous Flush

Device Record Status

Public Device Record Key

77384db1-0c74-47a1-beb9-2d8962a4604d

Public Version Date

December 22, 2021

Public Version Number

9

DI Record Publish Date

July 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEQUENT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4
3 A medical device with high risk that requires premarket approval 40