Catalog Number

-

Brand Name

Knot Pusher

Version/Model Number

2901-350

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

HCF

Product Code Name

INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Public Device Record Key

83892e17-6cce-402c-b823-e394ad285493

Public Version Date

June 18, 2021

Public Version Number

1

DI Record Publish Date

June 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-