Dover - Silicone Elastomer Coated Latex Foley Catheter,5 - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way

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More Product Details

Catalog Number

8887688268

Brand Name

Dover

Version/Model Number

8887688268

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Device Record Status

Public Device Record Key

b20a65b1-2e6e-4401-b8a4-a617b95b6bbf

Public Version Date

October 28, 2019

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10884521017092

Quantity per Package

10

Contains DI Package

30884521017096

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