Lumo Cuff, STD-MED-B

Basic Information

• Brand Name: Lumo Cuff, STD-MED-B
• Primary DI: 04262429650587
• Version / Model: 03012002
• Company Name: macu4 GmbH
• Labeler DUNS: 344157954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-23
• Public Version: 1
• Public Version Date: 2025-12-01
• Public Version Status: New
• Public Device Record Key: 2659c42b-0932-471f-81bd-95463bacf58b

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: MR Unsafe
• 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
ILT	Adaptor, Recreational	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41459	Wrist/hand orthosis	An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262429650587	GS1