SharpSafety - Multi-Glove Box Dispenser,Side Loading - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Multi-Glove Box Dispenser,Side Loading

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More Product Details

Catalog Number

8555SA

Brand Name

SharpSafety

Version/Model Number

8555SA

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

-

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

FOX

Product Code Name

STAND, INFUSION

Device Record Status

Public Device Record Key

705e59fd-9753-431d-9e3b-5eec49412109

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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