DEVICE: NA (00845384011743)

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Device Record History
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Device Identifier (DI) Information
NA
E-FP-DIR/IRR
In Commercial Distribution
E-FP-DIR/IRR
Synthes GmbH
00845384011743
GS1
October 01, 2025
1
486711679 *Terms of Use
Electric Systems Foot Control With Direction and Irrigation
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
36336 Foot-switch, electrical
An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HBF DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K011444 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
81256092-4e56-4376-a702-9abc150f4a55
June 12, 2025
7
September 09, 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

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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
RA-DPYNA-anspachpowe@its.jnj.com
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