Dover - Silver Coated 100% Silicone Foley Catheter, 30 - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Silver Coated 100% Silicone Foley Catheter, 30 ml, 3-Way

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More Product Details

Catalog Number

665241IC

Brand Name

Dover

Version/Model Number

665241IC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Device Record Status

Public Device Record Key

957903a5-7b23-4a6f-8fa9-882f4a8bb5d9

Public Version Date

December 04, 2020

Public Version Number

10

DI Record Publish Date

June 27, 2017

Additional Identifiers

Package DI Number

10884521723412

Quantity per Package

10

Contains DI Package

20884521723419

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