Catalog Number

P10176

Brand Name

LaproShark

Version/Model Number

P10176

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"

-

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

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Public Device Record Key

37a73c49-9ff6-4fc0-9961-a9ec9baeddbc

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

00860003665060

Quantity per Package

10

Contains DI Package

00860003665091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack