Adlite™ Plus - ADLITE Plus Disp Penlight,Teal - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: ADLITE Plus Disp Penlight,Teal

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More Product Details

Catalog Number

356TL

Brand Name

Adlite™ Plus

Version/Model Number

356TL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KYT

Product Code Name

Light, Examination, Medical, Battery Powered

Device Record Status

Public Device Record Key

2f0b2c0f-4e4c-4457-ac7e-52761100fbbd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

00634782540104

Quantity per Package

60

Contains DI Package

00634782840105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"AMERICAN DIAGNOSTIC CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2395
2 A medical device with a moderate to high risk that requires special controls. 1769