OptiHair2

Basic Information

• Brand Name: OptiHair2
• Primary DI: 04262355232109
• Version / Model: VF
• Company Name: MRC SYSTEMS GmbH Medizintechnische Systeme
• Labeler DUNS: 313871451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 3d8552f8-7233-43a2-a7ac-2f0431d42e6b

Device Description

The "OptiHair2" - von Frey filaments are used to investigate the tactile detection threshold in quantitative sensory testing (QST).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
GXB	Esthesiometer	Neurology	882.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47164	Point aesthesiometer	A manual stimulator designed to determine tactile sensibility by patient response to the manual application of a thin filament(s) to the skin. It typically consists of a filament(s) with a pre-set flexibility and is intended to apply a known pressure upon application; the filament is attached to an appropriate handle/base that may also be intended to be loaded into a dedicated pen/holder. The device is typically used during diagnosis or treatment of nerve injuries and neuropathies associated with e.g., diabetes mellitus or leprosy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262355232109	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]