FDA UDI
In Commercial Distribution
🇺🇸 United States
Laser Thermal Therapy Kit L E
DI: 08052286590227
·
Model: EI KT0 0011 002
·
ELESTA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Laser Thermal Therapy Kit L E
- Primary DI
- 08052286590227
- Version / Model
- EI KT0 0011 002
- Company Name
- ELESTA SPA
- Labeler DUNS
- 895683282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-06
- Public Version
- 1
- Public Version Date
- 2023-11-14
- Public Version Status
- New
- Public Device Record Key
- 38911ecd-6d1f-429a-a159-d4d1853848ec
Device Description
The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272micron core quartz-quartz fiber with distal end outer diameter 420micron and NA 0.2) and an introducer needle (21G). The device is sterile and single use.
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62600 | General/multiple surgical laser system beam guide, single-use | A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052286590227 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230460 | 000 |