NA - Replacement filter for: StrykeVac - Conmed Corporation

Duns Number:071595540

Device Description: Replacement filter for: StrykeVac

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More Product Details

Catalog Number

VSSV301

Brand Name

NA

Version/Model Number

VSSV301

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

-

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

K930041,K930041

Product Code Details

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Device Record Status

Public Device Record Key

c5cd274f-c83a-4bb3-989a-a7f40a6bc041

Public Version Date

April 22, 2022

Public Version Number

2

DI Record Publish Date

June 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95