Z-Brand™ - 50 PER POUCH, 20 POUCHES PER CASE, 1000/CASE - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

Device Description: 50 PER POUCH, 20 POUCHES PER CASE, 1000/CASE

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More Product Details

Catalog Number

6503023V

Brand Name

Z-Brand™

Version/Model Number

Z05MTRT-50 USA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

97ffd5df-9ecc-4e5d-9222-174376c16da3

Public Version Date

December 02, 2020

Public Version Number

3

DI Record Publish Date

April 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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