Catalog Number

AS01099-KIT-3

Brand Name

ALPHA SOURCE BATTERY

Version/Model Number

AS01099-KIT-3

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

K931200

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

2495789b-044a-48e6-a514-f00ec15ee96c

Public Version Date

July 10, 2019

Public Version Number

1

DI Record Publish Date

July 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-