VIA - The VIA Procedure Kit custom includes Transport - US Endoscopy

Duns Number:627879687

Device Description: The VIA Procedure Kit custom includes Transport Pad, gauze, basin, enzymatic sponge, lubr The VIA Procedure Kit custom includes Transport Pad, gauze, basin, enzymatic sponge, lubricating jelly, suction tubing, channel brush, and gown.

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More Product Details

Catalog Number

00717432

Brand Name

VIA

Version/Model Number

00717432

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

NWU

Product Code Name

Endoscope introducer kit

Device Record Status

Public Device Record Key

9685adf6-0057-4f68-9993-4aad3942fb7c

Public Version Date

February 15, 2022

Public Version Number

1

DI Record Publish Date

February 07, 2022

Additional Identifiers

Package DI Number

10724995217331

Quantity per Package

12

Contains DI Package

00724995217334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902