Argyle - Saratoga Sump Drain - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Saratoga Sump Drain

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More Product Details

Catalog Number

8888531038

Brand Name

Argyle

Version/Model Number

8888531038

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

61bad91c-4d4a-44e0-8c1b-7cbd53a1dd61

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Additional Identifiers

Package DI Number

20884521071886

Quantity per Package

10

Contains DI Package

10884521071889

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