FDA.report

LYNX

Primary DI
08057147028963
Brand
LYNX
Company
UNIVET LOUPES SPA
Model
LYNX
Catalog number
KKA183418
Device description
Lighting system
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications

CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08057147028963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08057147028963080571470289638057147028963

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

Regulatory Flags

DUNS number
431093237
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08057147028970LYNX PROLYNX PROKKA1835182026-03-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00840277407030MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17