Catalog Number

VBT0810

Brand Name

AVAmax

Version/Model Number

VBT0810

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

789383f8-55c0-48ab-972e-fd44ebbfad6d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

50885403001916

Quantity per Package

5

Contains DI Package

10885403001918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS