FDA.reportPublic FDA data

TISSIUM® LIGHT

Primary DI
03760279380056
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.888.847.7486customercare@tissium.com

Regulatory Flags#

DUNS number
265137228
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
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
03760279380063TISSIUM® 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
03760279380063TISSIUM® LIGHTTISSIUMSFD2025-09-20