beyond scrubs® - EKG Caliper,Pewter, SB PL, Disp pkg - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: EKG Caliper,Pewter, SB PL, Disp pkg

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More Product Details

Catalog Number

395SBQ

Brand Name

beyond scrubs®

Version/Model Number

395SBQ

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

a82d6e71-6312-4de7-8ea0-c0e70bd19df5

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

00634782558550

Quantity per Package

4

Contains DI Package

00634782858551

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