| Primary Device ID | M473204440 |
| NIH Device Record Key | 8fb69e47-bbdc-40db-8d09-d2c9abef4004 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trimedyne® VaporMAX® - Ho:YAG Side Firing Fiber-Optic Instrument |
| Version Model Number | 20444 |
| Catalog Number | 20444 |
| 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 | M473204440 [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 |
| M47320444SMA0 | VaporMax Sidefiring Fiber, SMA Connector |
| M473204440 | VaporMax Sidefiring Fiber, TMED Connector |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRIMEDYNE 74055774 1636817 Live/Registered |
Trimedyne, Inc. 1990-05-04 |