Medipin

Basic Information

• Brand Name: Medipin
• Primary DI: 05060631140006
• Version / Model: Medipin Pack of 100 Esthesiometers/Sensory Testers
• Catalog Number: MP-100
• Company Name: MEDIPIN LIMITED
• Labeler DUNS: 737328851
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-03-25
• Public Version: 3
• Public Version Date: 2023-06-26
• Public Version Status: Update
• Public Device Record Key: 65be2e12-4e21-4970-abe1-65f0808e10eb

Device Description

A box of 100 Single-Use Protected Neurological Pins - A disposable precision esthesiometer for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
64709	Neurological pain-testing pin	A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060631140006	GS1
Unit of Use	05060631140020	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	80	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius