Elevate ArmBoard Extender

Basic Information

• Brand Name: Elevate ArmBoard Extender
• Primary DI: 10815614020859
• Version / Model: 8100-EXT-U
• Catalog Number: 180-0100-EXT-U
• Company Name: SEMLER TECHNOLOGIES, INC.
• Labeler DUNS: 042075700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-17
• Public Version: 1
• Public Version Date: 2022-11-25
• Public Version Status: New
• Public Device Record Key: d65938c5-1f31-43b0-a061-e03c35ac775e

Device Description

The refurbished Elevate ArmBoard Extender Model 8100-EXT-U is an ArmBoard accessory that provides additional workspace when used with an Elevate ArmBoard.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMQ	Restraint, Protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40900	Radiological arm/leg positioner	A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815614020859	GS1