ADC® - EKG Ruler,1 & 2 Cycle Scales - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: EKG Ruler,1 & 2 Cycle Scales

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More Product Details

Catalog Number

394

Brand Name

ADC®

Version/Model Number

394

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

FTY

Product Code Name

Tape, Measuring, Rulers And Calipers

Device Record Status

Public Device Record Key

01f98c76-bc26-41d8-829b-e3b18a5c9b46

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

00634782536756

Quantity per Package

15

Contains DI Package

00634782836757

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