| Primary Device ID | M47320362SMA0 | 
| NIH Device Record Key | d5173bc9-6467-4b26-81b0-f01c08c54ca4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Trimedyne® Ho:YAG Side Firing 29 cm Laser Needle (SMA Connector) | 
| Version Model Number | 20362-SMA | 
| Catalog Number | 20362-SMA | 
| Company DUNS | 057007239 | 
| Company Name | TRIMEDYNE, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | M47320362SMA0 [Primary] | 
| GEX | Powered Laser Surgical Instrument | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2020-02-27 | 
| Device Publish Date | 2018-07-11 | 
| M47321200 - Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System | 2023-06-22 Model 2120 - OmniPulse Mini Holmium Laser System | 
| M47312100 - Trimedyne® 1210 OmniPulse™ Holmium Laser System | 2020-02-27 Model 1210 - OmniPulse Holmium Laser System | 
| M4731210VHP0 - Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System | 2020-02-27 Model 1210-VHP - OmniPulse Max Holmium Laser System | 
| M4731210VHPA0 - Trimedyne® 1210-VHPA OmniPulse Max™ Holmium Laser System | 2020-02-27 Model 1210-VHPA - OmniPulse Max Holmium Laser System | 
| M4731230300 - Trimedyne® 1230-30 OmniPulse Jr.™ Holmium Laser System | 2020-02-27 Model 1230-30 - OmniPulse Jr. Holmium Laser System | 
| M4731500A0 - Trimedyne® Model 1500-A Holmium Laser System | 2020-02-27 Model 1500-A - Holmium Laser System | 
| M47320021M0 - Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber | 2020-02-27 Fiber, Bare, 550um, Reusable, TMED Connector | 
| M47320021MSMA0 - Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber (SMA Connector) | 2020-02-27 Fiber, Bare, 550um, Reusable, SMA Connector | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TRIMEDYNE  74055774  1636817 Live/Registered | Trimedyne, Inc. 1990-05-04 |