Dermacea - Stretch Bandage - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Stretch Bandage

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More Product Details

Catalog Number

2260

Brand Name

Dermacea

Version/Model Number

2260

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

FQM

Product Code Name

BANDAGE, ELASTIC

Device Record Status

Public Device Record Key

1e4d6121-50da-4fab-a9ec-576e37e494a2

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

June 28, 2018

Additional Identifiers

Package DI Number

20884527015662

Quantity per Package

12

Contains DI Package

10884527015665

Package Discontinue Date

-

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