Primary Device ID | M47320497HP1 |
NIH Device Record Key | 26a43c0e-7f12-4f55-bede-b22149222b99 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight |
Version Model Number | 20497-HP |
Catalog Number | 20497-HP |
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 | M47320497HP0 [Primary] |
HIBCC | M47320497HP1 [Package] Contains: M47320497HP0 Package: Carton [5 Units] In Commercial Distribution |
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 |
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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 |