PerformancePlus™ - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

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More Product Details

Catalog Number

A10012-4-60S

Brand Name

PerformancePlus™

Version/Model Number

A10012-4-60S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 20, 2021

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"

Yes

For Single-Use

Yes

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

-

Product Code Details

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

32754814-4188-4706-a6d8-e58f59879029

Public Version Date

August 23, 2021

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

80813150020622

Quantity per Package

60

Contains DI Package

70813150020625

Package Discontinue Date

August 20, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"GRAPHIC CONTROLS ACQUISITION CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161
2 A medical device with a moderate to high risk that requires special controls. 269
3 A medical device with high risk that requires premarket approval 1