CARDINAL HEALTH - Self-Adherent Latex Bandage 2" x5yd; Sterile; For - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Self-Adherent Latex Bandage 2" x5yd; Sterile; For Single Use Only; Store in a cool, dry pl Self-Adherent Latex Bandage 2" x5yd; Sterile; For Single Use Only; Store in a cool, dry place. Caution: This product contains natural rubber latex which may cause allergic reactions.

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More Product Details

Catalog Number

CAH25S

Brand Name

CARDINAL HEALTH

Version/Model Number

CAH25S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

091757a3-288a-4431-af84-a82ca14b16b8

Public Version Date

July 08, 2019

Public Version Number

1

DI Record Publish Date

June 30, 2019

Additional Identifiers

Package DI Number

50885380004429

Quantity per Package

24

Contains DI Package

00885380004424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40