LION

Basic Information

• Brand Name: LION
• Primary DI: 08809204330560
• Version / Model: HT-B10
• Company Name: Hans Biomed Corp.
• Labeler DUNS: 689512625
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-26
• Public Version: 1
• Public Version Date: 2025-12-04
• Public Version Status: New
• Public Device Record Key: b87df619-4837-47b6-a766-ccd2b92580a8

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62985	Hair implantation unit	A sterile, hand-held, manual device intended to be used during a hair transplantation procedure (follicular transplantation) to implant hair follicles into the scalp, typically for the treatment of male pattern baldness. It consists of: 1) a dedicated needle(s) intended to be loaded with a hair follicle; and 2) a pen-like handpiece (implanter) with a manual plunger-like mechanism intended to deploy/implant the follicle from the needle. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809204330560	GS1