AccessGUDID - DEVICE: MotoBAND (00815432022724)

GUDID

Device Identifier (DI) Information

Brand Name: MotoBAND
Version or Model: MotoBAND CP Plate Fixation Pin - Sterile
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1500-0001
Company Name: CROSSROADS EXTREMITY SYSTEMS

Primary DI Number: 00815432022724
Issuing Agency: GS1
Commercial Distribution End Date: June 27, 2024
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. When used for these indications, certain plates within this system may be used with the MotoCLIP Implant System

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?
47746	Bone tack inserter, basic	A hand-held manual surgical instrument designed to drive (insert) a tack into bone, typically to fixate an orthopaedic plate or sheet. It is typically formed with a shaft made of high-grade stainless steel and a handle at the proximal end made of metal or synthetic material. The distal end is designed to hold (grip) the head of the tack head during insertion, typically through a hole in the plate or sheet and into a pre-drilled hole in the bone. This is a reusable device.	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
K160300	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eae37395-e9b2-424f-84f7-1c8dc17667f5
Public Version Date: June 28, 2024
Public Version Number: 5
DI Record Publish Date: May 10, 2016