Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector) S365SMA
GUDID M473S365SMA1
Fiber, Bare, 365um, Single Use, SMA Connector
TRIMEDYNE, INC.
General/multiple surgical laser system beam guide, single-use, sterile| Primary Device ID | M473S365SMA1 |
| NIH Device Record Key | f3544cb9-ad2a-496e-a578-b2b6fb727b41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector) |
| Version Model Number | S365SMA |
| Catalog Number | S365SMA |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M473S365SMA0 [Primary] |
| HIBCC | M473S365SMA1 [Package] Contains: M473S365SMA0 Package: Carton [3 Units] In Commercial Distribution |
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2018-07-11 |
Devices Manufactured by TRIMEDYNE, INC.
| 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 |
Trademark Results [Trimedyne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIMEDYNE 74055774 1636817 Live/Registered |
Trimedyne, Inc. 1990-05-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.