DEVICE: NA (07613252286677)

Device Identifier (DI) Information

NA
6006-112-010
In Commercial Distribution
6006-112-010
Stryker Leibinger GmbH & Co. KG
07613252286677
GS1

1
316153956 *Terms of Use
12'' FLUORODISC BELT
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multi-purpose stereotactic surgery system An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.
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FDA Product Code

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Product Code Product Code Name
OLO Orthopedic stereotaxic instrument
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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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify: TRANSPORTATION: 10%-95% / -40¿C-70¿C
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter: 12.0 Inch
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Device Record Status

f39e930a-7f11-4d91-af2b-42560f36a354
March 29, 2018
2
September 15, 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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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