AccessGUDID - DEVICE: MotoBAND (00815432022625)

GUDID

Device Identifier (DI) Information

Brand Name: MotoBAND
Version or Model: MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 130102
Company Name: CROSSROADS EXTREMITY SYSTEMS

Primary DI Number: 00815432022625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058864308 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

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 [?]
K152306	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 12 Millimeter
Outer Diameter: 3.5 Millimeter

Device Record Status

Public Device Record Key: 6ab91cb8-6422-45ab-83d6-5eabc52d1967
Public Version Date: June 10, 2024
Public Version Number: 5
DI Record Publish Date: December 14, 2015