DEVICE: POWER DRIVE ART1 (04055207012246)

Device Identifier (DI) Information

POWER DRIVE ART1
2304007
In Commercial Distribution
2304.007
Richard Wolf GmbH
04055207012246
GS1

1
315304071 *Terms of Use
MOTOR CONTROL UNIT 2304 for Orthopedics, Spine surgery and Bronchoscopy, for connection of handpieces M4, M5/0, M5/3, S1 und M1, connection for two handpieces and a footswitch, 5.7" monochrome Display, compatible with core, U: 120VAC, 50/60Hz, Dim. (wxhxd): 330x155x365mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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 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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FDA Product Code

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Product Code Product Code Name
HRX ARTHROSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0ff2579f-4ab4-4527-a246-7d5222e7caac
March 29, 2018
2
July 21, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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