VueTip - Trocar Swab Accessory Kit - Buffalo Filter

Duns Number:787855907

Device Description: Trocar Swab Accessory Kit

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More Product Details

Catalog Number

-

Brand Name

VueTip

Version/Model Number

VUETIP10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

b848e5ca-e9f7-4334-a11e-b289c1257cc6

Public Version Date

April 22, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10815198012363

Quantity per Package

10

Contains DI Package

00815198012366

Package Discontinue Date

April 21, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"BUFFALO FILTER" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 104