FDA UDI
In Commercial Distribution
🇺🇸 United States
Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System
DI: M47321200
·
Model: 2120
·
TRIMEDYNE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System
- Primary DI
- M47321200
- Version / Model
- 2120
- Catalog Number
- 2120
- Company Name
- TRIMEDYNE, INC.
- Labeler DUNS
- 057007239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 18e8f38f-68bf-4730-9316-eed80d7396d2
Device Description
Model 2120 - OmniPulse Mini Holmium Laser System
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36170 | General/multiple surgical solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M47321200 | HIBCC |
Customer Contacts
- Phone
- 8007335273
- [email protected]