Catalog Number

GA676

Brand Name

ACCULAN

Version/Model Number

GA676

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

MOQ

Product Code Name

BATTERY, REPLACEMENT, RECHARGEABLE

Public Device Record Key

153ec4f3-27e8-4b47-b215-ace263a98212

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-