Devon - True content to be populated as part of rebranding - Cardinal Health, Inc.

Duns Number:080935429

Device Description: True content to be populated as part of rebranding

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More Product Details

Catalog Number

52000040

Brand Name

Devon

Version/Model Number

52000040

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2019

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

-

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

-

FDA Premarket Submission

K040052,K040052

Product Code Details

Product Code

HFX

Product Code Name

CLAMP, CIRCUMCISION

Device Record Status

Public Device Record Key

4b2fac35-8dcf-44cb-86d1-75013155a30d

Public Version Date

July 01, 2019

Public Version Number

8

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10884527023127

Quantity per Package

20

Contains DI Package

20884527023124

Package Discontinue Date

July 01, 2019

Package Status

Not 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