DEVICE: POWER DRIVE ART1 (04055207012246)
Device Identifier (DI) Information
POWER DRIVE ART1
2304007
In Commercial Distribution
2304.007
Richard Wolf GmbH
2304007
In Commercial Distribution
2304.007
Richard Wolf GmbH
MOTOR CONTROL UNIT 2304 for Orthopedics, Spine surgery and Bronchoscopy, for connection of handpieces M4, M5/0, M5/3, S1 and M1, connection for two handpieces and a footswitch, 5.7inch monochrome Display, compatible with core, U: 120VAC, 50/60Hz, Dim. (wxhxd): 330x155x365mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
41264 | Surgical power tool system control unit, line-powered |
A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0ff2579f-4ab4-4527-a246-7d5222e7caac
October 18, 2022
5
July 21, 2017
October 18, 2022
5
July 21, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com