FDA.reportPublic FDA data

TISSIUM® LIGHT

Primary DI
03760279380063
Brand
TISSIUM® LIGHT
Company
TISSIUM
Model
LTIOP0001
Catalog number
LTIOP0001
Device description
The TISSIUM® LIGHT is a re-usable and non-sterile light source, indicated for the polymerization of TISSIUM® polymers.It is composed of two light pens, each with an internal rechargeable battery delivering a LED signal and one charging base with its power supply, including three adapter plugs (EU, UK and US).
Published
2025-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SFDIn Situ Polymerizing Peripheral Nerve Repair Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFDIn Situ Polymerizing Peripheral Nerve Repair DeviceNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760279380056Direct MarkingGS10
03760279380063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760279380056037602793800563760279380056
03760279380063037602793800633760279380063

GMDN Terms#

Term, Definition table
TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stored at room temperature, on a clean, dry and flat area, away from heat sources.

Contacts#

Phone, Email table
PhoneEmail
1.888.847.7486customercare@tissium.com

Regulatory Flags#

DUNS number
265137228
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760279380377COAPTIUM® SelectorNCOSE0001NCOSE00012025-10-03
03760279380070COAPTIUM® ConnectNCOCO1510NCOCO15102025-09-22
03760279380087COAPTIUM® ConnectNCOCO1575NCOCO15752025-09-22
03760279380094COAPTIUM® ConnectNCOCO2010NCOCO20102025-09-22
03760279380100COAPTIUM® ConnectNCOCO2075NCOCO20752025-09-22
03760279380117COAPTIUM® ConnectNCOCO3010NCOCO30102025-09-22
03760279380124COAPTIUM® ConnectNCOCO3015NCOCO30152025-09-22
03760279380131COAPTIUM® ConnectNCOCO3075NCOCO30752025-09-22
03760279380148COAPTIUM® ConnectNCOCO4010NCOCO40102025-09-22
03760279380155COAPTIUM® ConnectNCOCO4015NCOCO40152025-09-22
03760279380162COAPTIUM® ConnectNCOCO4075NCOCO40752025-09-22
03760279380179COAPTIUM® ConnectNCOCO5010NCOCO50102025-09-22
03760279380186COAPTIUM® ConnectNCOCO5015NCOCO50152025-09-22
03760279380193COAPTIUM® ConnectNCOCO5075NCOCO50752025-09-22
03760279380209COAPTIUM® ConnectNCOCO6010NCOCO60102025-09-22
03760279380216COAPTIUM® ConnectNCOCO60152025-09-22
03760279380223COAPTIUM® ConnectNCOCO6075NCOCO60752025-09-22
03760279380056TISSIUM® LIGHTLTIOP0001LTIOP00012025-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760279380070COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380087COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380094COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380100COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380117COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380124COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380131COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380148COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380155COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380162COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380179COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380186COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380193COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380209COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380216COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380223COAPTIUM® ConnectTISSIUMSFD2025-09-22
03760279380056TISSIUM® LIGHTTISSIUMSFD2025-09-20