Catalog Number

AFB1120

Brand Name

AVAflex

Version/Model Number

AFB1120

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

HRX

Product Code Name

Arthroscope

Public Device Record Key

77e75d9d-c8ea-41d1-abe2-99f62059f05b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2016

Package DI Number

50885403241183

Quantity per Package

5

Contains DI Package

10885403241185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS