Y-Knot - Y-Knot Flex Disposable Percutaneous Pack For - Conmed Corporation

Duns Number:071595540

Device Description: Y-Knot Flex Disposable Percutaneous Pack For Y-G00X Reusable Guides

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More Product Details

Catalog Number

Y-PERC

Brand Name

Y-Knot

Version/Model Number

Y-PERC

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Device Record Status

Public Device Record Key

c08085a1-a015-4e2c-9721-c886a6c3e5a5

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

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