DEVICE: canturio™te Canary Tibial Ext 14x58mm X-Ray Template (00850015699092)

Device Identifier (DI) Information

canturio™te Canary Tibial Ext 14x58mm X-Ray Template
43-5570-004-14
In Commercial Distribution

Canary Medical USA LLC
00850015699092
GS1

1
117153396 *Terms of Use
The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
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Device Characteristics

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

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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?
46479 Surgical implant template, reusable
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
QPP Implantable Post-Surgical Kinematic Measurement Knee Device
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN200064 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

3a7914f9-7c2e-4fd1-ac05-1182ffe80b03
September 30, 2021
1
September 22, 2021
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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
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Yes
No
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Customer Contact

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No Customer Contact currently defined
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