DEVICE: NA (07613327311822)

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Device Record History
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Device Identifier (DI) Information
NA
0101-0001
In Commercial Distribution
0101-0001
Stryker GmbH
07613327311822
GS1

1
481999654 *Terms of Use
ADAPT 2.0 for Gamma3 Software
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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?
60723 Medical image management system
A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OLO Orthopedic stereotaxic instrument
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K173946 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 85 Degrees Celsius
Handling Environment Temperature: between -25 and 85 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
2f0ba9c8-b692-4a15-99d1-95ed6574d06c
April 14, 2025
3
September 14, 2018
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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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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