DEVICE: MotoBAND (00815432022625)

Device Identifier (DI) Information

MotoBAND
MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm
In Commercial Distribution
130102
CROSSROADS EXTREMITY SYSTEMS
00815432022625
GS1

1
058864308 *Terms of Use
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.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HRS Plate, Fixation, Bone
HWC Screw, Fixation, Bone
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152306 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 12 Millimeter
Outer Diameter: 3.5 Millimeter
CLOSE

Device Record Status

6ab91cb8-6422-45ab-83d6-5eabc52d1967
June 10, 2024
5
December 14, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
901-221-8406
info@crextremity.com
CLOSE