Catalog Number

-

Brand Name

Avalign

Version/Model Number

VM84-26325

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

GZT

Product Code Name

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Public Device Record Key

9f38c771-73d6-4526-baf4-b562ffd3e10f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-