One Button Response Unit

Basic Information

• Brand Name: One Button Response Unit
• Primary DI: 07290103039073
• Version / Model: OBRU
• Catalog Number: DT 00012
• Company Name: MEDOC LTD.
• Labeler DUNS: 600469191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: bd385a94-2a24-4234-9459-2bde03319162

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HRW	Dynamometer, Nonpowered	Orthopedic	888.1250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62780	Pressure algometer/aesthesiometer, electronic	An electrically-powered digital instrument designed to measure: 1) a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force (pressure) to the skin; and 2) tactile sensibility (two-point touch discrimination) by application of a thin filament(s) to the skin. It is a hand-held device with a thin filament(s) with a pre-set flexibility intended to apply a known pressure (e.g., two-point aesthesiometer). It is typically used during diagnosis or treatment of nerve injuries and neuropathies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290103039073	GS1