Micro Suture Pusher and Knot Tier, Straight Handle, 185mm Kogent - Each, Suture Knot Pusher, Reusable, Micro, 185mm - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: Each, Suture Knot Pusher, Reusable, Micro, 185mm

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More Product Details

Catalog Number

-

Brand Name

Micro Suture Pusher and Knot Tier, Straight Handle, 185mm Kogent

Version/Model Number

N2901-K

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)

-

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

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Device Record Status

Public Device Record Key

1f700f96-3bc1-4bf2-8236-84110a4162aa

Public Version Date

May 12, 2020

Public Version Number

1

DI Record Publish Date

May 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATALYST SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1640
2 A medical device with a moderate to high risk that requires special controls. 288