Primary Device ID | 00817495022161 |
NIH Device Record Key | e24f9809-a701-4d3a-a9da-678ed04b6e2f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Alex TriVantage 3MM Handpiece Assembly |
Version Model Number | 7122-00-1051 |
Company DUNS | 053468385 |
Company Name | CANDELA CORPORATION |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
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 |
---|---|
GS1 | 00817495022161 [Primary] |
GS1 | 08174950202165 [Previous] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-06-17 |
Device Publish Date | 2016-09-23 |
00817495024677 - PicoWay Laser System | 2024-10-21 PicoWay Laser System |
00817495023540 - PicoWay Laser System | 2024-10-14 Picoway Laser System |
00817495023663 - PicoWay Laser System | 2024-10-14 Picoway Laser System |
00817495023588 - PicoWay Laser System | 2024-10-08 Picoway Laser System |
00817495024639 - GYAG Pro U Laser System | 2024-10-02 GYAG Pro U Laser System |
00817495024646 - Glase Pro U Laser System | 2024-10-02 Glase Pro U Laser System |
00817495024653 - GMAX Pro Laser System | 2024-10-02 GMAX Pro Laser System |
00817495024660 - GMAX Pro Plus Laser System | 2024-10-02 GMAX Pro Plus Laser System |