Devon - Surgical Site Mini-Marker,Prep Resistant - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Surgical Site Mini-Marker,Prep Resistant

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More Product Details

Catalog Number

31146020

Brand Name

Devon

Version/Model Number

31146020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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

FZZ

Product Code Name

MARKER, SKIN

Device Record Status

Public Device Record Key

7be3adc0-47d2-48a6-8bed-62e5737ca9fc

Public Version Date

September 22, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

20884521049816

Quantity per Package

100

Contains DI Package

30884521049813

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17