N/A - Bipolar Cord Set, Disposable - STRYKER CORPORATION

Duns Number:196548481

Device Description: Bipolar Cord Set, Disposable

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More Product Details

Catalog Number

6790-100-005

Brand Name

N/A

Version/Model Number

6790-100-005

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

616e7dd6-a9d1-4e81-bae3-77337eb0e0ce

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 03, 2017

Additional Identifiers

Package DI Number

37613327304269

Quantity per Package

10

Contains DI Package

07613327304268

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