FDA.report

Hayden Medical

Primary DI
00840319715390
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
BiLumixHLP-V2
Catalog number
BiLumixHLP-V2
Device description
BiLumix Shadowless Headlamp V2 Package includes - Headlamp - 2 Rechargable Batteries - 1 Charger - Attachable Light Source Cap (transparent, daylight and warm) - Headlight Bag, 1.5x Loupe
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HPPHeadlamp, operating, battery-operated

Product Code Classifications

CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840319715390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319715390008403197153908403197153900840319715390

GMDN Terms

TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags

DUNS number
618214410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840319723944Hayden Medical300-007300-0072022-08-16
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08057147028963LYNXUNIVET LOUPES SPAHPP2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPAHPP2026-03-02
00810186670214Enova IlluminationEnova Illumination, Inc.HPP2026-02-27
00860015454782RocotoRocoto Inc.HPP2026-02-26
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670139Enova IlluminationEnova Illumination, Inc.HPP2025-08-18
00194613122683MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
00194613122690MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
00840183529680BR Surgical, LLCBR Surgical, LLCHPP2025-07-16
00840183529970BR Surgical, LLCBR Surgical, LLCHPP2025-07-16
00860014100680AmimonRocoto Inc.HPP2025-06-24
00850061395016RONINRonin Surgical Corp.HPP2025-06-06
00860013851545C3QED, INC.HPP2025-05-21
00860013851552Centauri 2QED, INC.HPP2025-05-21
00817157020832AmimonAMIMON LTDHPP2025-04-03
00840277406941MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406958MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406965MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406972MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406989MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406996MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407009MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407016MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407023MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17