FDA.reportPublic FDA data

LYNX PRO

Primary DI
08057147028970
Brand
LYNX PRO
Company
UNIVET LOUPES SPA
Model
LYNX PRO
Catalog number
KKA183518
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

Product Codes#

Code, Name table
CodeName
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057147028970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057147028970080571470289708057147028970

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057147028963LYNXLYNXKKA1834182026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057147028963LYNXUNIVET 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