N/A - Integrated Tubing and Bipolar Cord Set, - STRYKER CORPORATION

Duns Number:196548481

Device Description: Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug

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More Product Details

Catalog Number

6790-100-002

Brand Name

N/A

Version/Model Number

6790-100-002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

0e085030-8225-4fc9-b657-c7aa159c9077

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

January 03, 2017

Additional Identifiers

Package DI Number

37613327304252

Quantity per Package

10

Contains DI Package

07613327304251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60