Sense Mirror

Basic Information

• Brand Name: Sense Mirror
• Primary DI: 07392532176494
• Version / Model: 3895
• Catalog Number: 3895
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-13
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 1cf56f91-2cab-44ec-83d4-091ad90f55e2
• Distribution End Date: 2022-04-11

Device Description

Urinary catheter positioning mirror

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: 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
FTX	MIRROR, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45295	Urethral self-catheterization assistive mirror	A device designed to reflect undiffused light to assist a disabled person with the self-placement and positioning of a urinary drainage/irrigation catheter (not included) by helping them to see a virtual image of and locate their own urethral orifice. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07392532176494	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	70	Millimeter
Length	125	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place at room temperature.