Catalog Number

-

Brand Name

2.7 mm Endoscopic Release System

Version/Model Number

4500-99

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

d2303ec8-44a3-4a73-bb50-9a39f7a3320f

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Package DI Number

10857915007511

Quantity per Package

5

Contains DI Package

00857915007514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case