Primary Device ID | 08174950200116 |
NIH Device Record Key | 4f2fcd4d-0e44-4b74-9260-404424d322b6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GentleYAG |
Version Model Number | 9914-00-0950 |
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 |
Phone | 800-735-2737 |
customerservice@syneron-candela.com |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08174950200116 [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 | 4 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2016-09-23 |
08174950200123 | Pulsed Laser |
08174950200116 | Pulsed Laser |
00817495020129 | Pulsed Laser |
00817495020112 | Pulsed Laser |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GENTLEYAG 76277865 2696488 Live/Registered |
Candela Corporation 2001-06-28 |