Primary Device ID | 00859932006037 |
NIH Device Record Key | d401ba1a-b9b3-4c9e-8d3a-87bf2a9f9998 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CoolTouch ReNew |
Version Model Number | R7300-0055 |
Catalog Number | LC225 |
Company DUNS | 877266163 |
Company Name | NEW STAR LASERS, 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 | 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 | 00859932006037 [Primary] |
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 | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-20 |
00859932006013 - StoneLight 15 | 2018-07-06 Ho:YAG Laser System |
00859932006211 - New Star Lasers | 2018-07-06 Fiber Optic Catheter |
00859932006228 - New Star Lasers | 2018-07-06 Fiber Optic Catheter |
00859932006235 - New Star Lasers | 2018-07-06 Fiber Optic Catheter |
00859932006242 - New Star Lasers | 2018-07-06 Fiber Optic Catheter |
00859932006006 - StoneLight 30 | 2018-03-29 Ho:YAG Laser System |
00859932006020 - CoolTouch CTEV | 2018-03-29 Nd:YAG Laser System |
00859932006037 - CoolTouch ReNew | 2018-03-29Nd:YAG Laser System |
00859932006037 - CoolTouch ReNew | 2018-03-29 Nd:YAG Laser System |