Uni-Patch - Compression Wrap - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Compression Wrap

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More Product Details

Catalog Number

MV75150

Brand Name

Uni-Patch

Version/Model Number

MV75150

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"

Yes

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

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

ee935e3e-c0c7-4275-8e09-7e354d2f8626

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 29, 2018

Additional Identifiers

Package DI Number

90884521190289

Quantity per Package

100

Contains DI Package

10884521190283

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