NA - High Performance Bi-Drive Bone Drill - Stryker Trauma GmbH

Duns Number:330211587

Device Description: High Performance Bi-Drive Bone Drill

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More Product Details

Catalog Number

5805-0-115

Brand Name

NA

Version/Model Number

5805-0-115

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

c6954bd7-866d-4c07-bf83-793050250120

Public Version Date

April 15, 2020

Public Version Number

1

DI Record Publish Date

April 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER TRAUMA GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 365
2 A medical device with a moderate to high risk that requires special controls. 2874