FDA.reportPublic FDA data

LION

Primary DI
08809204330652
Brand
LION
Company
Hans Biomed Corp.
Model
HTN-10
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAHStylet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809204330652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809204330652088092043306528809204330652

GMDN Terms#

Term, Definition table
TermDefinition
Hair implantation unitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689512625
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809963478848SurFuse II PuttySP032026-04-16
08809963478855SurFuse II PuttySP052026-04-16
08809963478862SurFuse II PuttySP12026-04-16
08809963478879ExFuse II PuttyEP032026-04-16
08809963478886ExFuse II PuttyEP052026-04-16
08809963478893ExFuse II PuttyEP12026-04-16
08809204337248ExFuseEG052015-09-24
08809204337255ExFuseEG12015-09-24
08809204337262ExFuseEG32015-09-24
08809204337279ExFuseEG52015-09-24
08809204337286ExFuseEG82015-09-24
08809204337293ExFuseEG102015-09-24
08809204337309ExFuseEP032015-09-24
08809204337316ExFuseEP052015-09-24
08809204337323ExFuseEP12015-09-24
08809204337330ExFuseEP32015-09-24
08809204337347ExFuseEP52015-09-24
08809204337354ExFuseEP82015-09-24
08809204337361ExFuseEP102015-09-24
08809204337583ExFuseEG032015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663192873Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192897Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192903Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192910Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192927Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
00873263009314Visualase Neuro AccessoriesFHC, INC.GAH2025-12-12
00873263009338Visualase MR Stiffening StyletFHC, INC.GAH2025-12-12
03662663131414Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131506Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131513Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131520Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131537Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
08809204330522LIONHans Biomed Corp.GAH2025-11-26
08809204330539LIONHans Biomed Corp.GAH2025-11-26
08809204330546LIONHans Biomed Corp.GAH2025-11-26
08809204330553LIONHans Biomed Corp.GAH2025-11-26
08809204330560LIONHans Biomed Corp.GAH2025-11-26
08809204330577LIONHans Biomed Corp.GAH2025-11-26
08809204330584LIONHans Biomed Corp.GAH2025-11-26
08809204330591LIONHans Biomed Corp.GAH2025-11-26
08809204330607LIONHans Biomed Corp.GAH2025-11-26
08809204330614LIONHans Biomed Corp.GAH2025-11-26
08809204330621LIONHans Biomed Corp.GAH2025-11-26
08809204330638LIONHans Biomed Corp.GAH2025-11-26
08809204330645LIONHans Biomed Corp.GAH2025-11-26
08809779585853LIONHans Biomed Corp.GAH2025-11-26
08809779585877LIONHans Biomed Corp.GAH2025-11-26
08809204330515LIONHans Biomed Corp.GAH2025-11-18
00873263009062Visualase Neuro AccessoriesFHC, INC.GAH2025-03-10
00873263009079Visualase MR Stiffening StyletFHC, INC.GAH2025-03-10