DEVICE: Stryker VariSpeed (07613252732044)

Device Identifier (DI) Information

Stryker VariSpeed
62-50200
In Commercial Distribution
62-50200
Stryker Leibinger GmbH & Co. KG
07613252732044
GS1

1
316153956 *Terms of Use
STRYKER VARISPEED
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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 screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 70 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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b8e21ecc-da39-45c7-9691-e2798de43245
October 05, 2018
4
October 19, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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