Catalog Number

VBT1320

Brand Name

AVAmax

Version/Model Number

VBT1320

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

7e8e5508-c80b-4949-9877-c5b3ec685c1f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2016

Package DI Number

50885403240919

Quantity per Package

5

Contains DI Package

10885403240911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS