Catalog Number

-

Brand Name

AmbiCanner

Version/Model Number

470-11-AM

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

549d5a03-a16e-4cd9-85ff-8ba9f3f67821

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

August 01, 2020

Package DI Number

10854947005980

Quantity per Package

24

Contains DI Package

00854947005983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box