DEVICE: QUIKDRIVE (04546540518675)

Download: XML | JSON

Device Identifier (DI) Information

QUIKDRIVE
62-50101
62-50101
Stryker Leibinger GmbH & Co. KG
04546540518675
GS1
1
QUIKDRIVE MINI
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical power tool system handpiece, rotary, non-rechargeable battery-powered A hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drills, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by a single-use sterile battery pack that normally will attach to, or is inserted into, the handpiece. The device may be cannulated to allow the use of a guidewire, and may be of the micro or macro design. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 60 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
October 19, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE