Devon - Custom Bagel - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Custom Bagel

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More Product Details

Catalog Number

572302

Brand Name

Devon

Version/Model Number

572302

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

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Device Record Status

Public Device Record Key

e8636e73-3a81-4e40-a4f6-2bb5dc955612

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Additional Identifiers

Package DI Number

10884527003860

Quantity per Package

36

Contains DI Package

20884527003867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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