DEVICE: NA (00845384011972)

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Device Record History
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Device Identifier (DI) Information
NA
SC2101
In Commercial Distribution
SC2101
Synthes GmbH
00845384011972
GS1
October 01, 2025
1
486711679 *Terms of Use
eMax 2 Plus Console, Single Port with 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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED
HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HBF DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K080802 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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
3c06c651-6dc1-44d2-a964-a72b7cbc9a0a
May 28, 2025
8
September 09, 2016
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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

[?]
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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