Neuropen Monofilaments 10g

Basic Information

• Brand Name: Neuropen Monofilaments 10g
• Primary DI: 00384700104016
• Version / Model: NT 0104
• Company Name: OWEN MUMFORD LIMITED
• Labeler DUNS: 217266915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-10-03
• Public Version: 1
• Public Version Date: 2019-10-11
• Public Version Status: New
• Public Device Record Key: e3f400a3-0669-42f7-9ef3-928cb0eec3fd

Device Description

Monofilaments for neuropathy screening

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
GXB	Esthesiometer	Neurology	882.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61581	Pressure algometer/aesthesiometer, mechanical	A manual, non-powered instrument designed to measure: 1) a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force to the skin; and 2) tactile sensibility by application of a thin filament(s) to the skin. It is typically a holder/pen which includes a strain gauge, a pressure algesimeter tip(s), and a thin filament(s) with a pre-set flexibility intended to apply a known pressure (point aesthesiometer). The device is typically used to evaluate the effects of pain after the use of anaesthesia/analgesics and/or during diagnosis or treatment of nerve injuries and neuropathies. This is a reusable device when the consumable products have been replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00384700104030	GS1	Case	20	In Commercial Distribution
Primary	00384700104016	GS1
Package	00384700104023	GS1	Sleeve	5	In Commercial Distribution
Unit of Use	00384700104009	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius