Catalog Number

-

Brand Name

EndoSleeve

Version/Model Number

2600

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

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

NBH

Product Code Name

Accessories, Arthroscopic

Public Device Record Key

a531c418-d2ba-49d2-adf6-ea67715f345b

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

August 13, 2018

Package DI Number

10857915007146

Quantity per Package

5

Contains DI Package

00857915007149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case