DEVICE: MotoBAND (00815432022625)
Device Identifier (DI) Information
MotoBAND
MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm
In Commercial Distribution
130102
CROSSROADS EXTREMITY SYSTEMS
MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm
In Commercial Distribution
130102
CROSSROADS EXTREMITY SYSTEMS
The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
66497 | Stress-therapy vibroacoustic headband |
An electrically-powered wearable device intended to apply vibroacoustic therapy (VAT) stimuli to the head to treat stress and sleep disorder symptoms (e.g., insomnia, migraine, anxiety) by inducing a state of brain relaxation. It is typically in the form of a headband to be positioned over the forehead and temporal areas of the head, and includes dedicated software for vibration frequency programming from a wirelessly connected smart device (not included). It is intended to be used in clinical and home settings.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | Plate, Fixation, Bone |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K152306 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 12 Millimeter |
Outer Diameter: 3.5 Millimeter |
Device Record Status
6ab91cb8-6422-45ab-83d6-5eabc52d1967
June 10, 2024
5
December 14, 2015
June 10, 2024
5
December 14, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
901-221-8406
info@crextremity.com
info@crextremity.com