NA - QUICK COUPLING FOR K-WIRES FOR BATTERY POWER LINE - Synthes GmbH

Duns Number:486711679

Device Description: QUICK COUPLING FOR K-WIRES FOR BATTERY POWER LINE

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More Product Details

Catalog Number

530790

Brand Name

NA

Version/Model Number

530.790

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)

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

GEY

Product Code Name

MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Device Record Status

Public Device Record Key

23af8b30-19bc-4faf-b493-3e19ced6e10a

Public Version Date

May 03, 2022

Public Version Number

3

DI Record Publish Date

February 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8630
2 A medical device with a moderate to high risk that requires special controls. 16671
U Unclassified 2