Devon - 1922 Foam Block Needle Counter - Cardinal Health, Inc.

Duns Number:080935429

Device Description: 1922 Foam Block Needle Counter

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More Product Details

Catalog Number

31142360

Brand Name

Devon

Version/Model Number

31142360

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

GAB

Product Code Name

NEEDLE, SUTURING, DISPOSABLE

Device Record Status

Public Device Record Key

dcef0990-eec0-4982-be3a-ec5295fb3873

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

June 23, 2018

Additional Identifiers

Package DI Number

10884527016402

Quantity per Package

12

Contains DI Package

30884527016406

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