FDA UDI
In Commercial Distribution
🇺🇸 United States
TISSIUM® LIGHT
DI: 03760279380063
·
Model: LTIOP0001
·
TISSIUM
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TISSIUM® LIGHT
- Primary DI
- 03760279380063
- Version / Model
- LTIOP0001
- Catalog Number
- LTIOP0001
- Company Name
- TISSIUM
- Labeler DUNS
- 265137228
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-20
- Public Version
- 1
- Public Version Date
- 2025-09-29
- Public Version Status
- New
- Public Device Record Key
- c7ad68b3-ecc5-44ee-a604-3f9fc016c9b1
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).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SFD | In Situ Polymerizing Peripheral Nerve Repair Device | Neurology | 882.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35775 | Dental/surgical polymerization lamp | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 03760279380056 | GS1 | ||||
| Primary | 03760279380063 | GS1 |
Customer Contacts
- Phone
- 1.888.847.7486
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stored at room temperature, on a clean, dry and flat area, away from heat sources.