Catalog Number

50.032.05

Brand Name

HIGH-FLOW Arthroscopy trocar sheath, OD6.5mm,w.2 rotatable stopcock,f.optic

Version/Model Number

50.032.05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NBH

Product Code Name

ACCESSORIES,ARTHROSCOPIC

Public Device Record Key

614622b2-7b08-4eef-8b47-dbd2f77214e3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH50032051

Quantity per Package

1

Contains DI Package

EMAH50032050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-