CARDINAL HEALTH - ProCare Lancets Ultra Fine - RGH ENTERPRISES

Duns Number:049735438

Device Description: ProCare Lancets Ultra Fine

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More Product Details

Catalog Number

ZPL10030PC

Brand Name

CARDINAL HEALTH

Version/Model Number

ZPL10030PC

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

Yes

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

FMK

Product Code Name

Lancet, blood

Device Record Status

Public Device Record Key

58f4a41e-e213-473e-8211-7a35d75abb1e

Public Version Date

June 14, 2019

Public Version Number

1

DI Record Publish Date

June 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RGH ENTERPRISES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 1