Catalog Number

PMI-ABB-22V

Brand Name

AVALIGN

Version/Model Number

PMI-ABB-22V

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"

-

For Single-Use

-

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

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

0cd2d0f8-4e4d-4ea7-aabe-27da66550026

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-