Primary Device ID | 03830054230347 |
NIH Device Record Key | 1464313c-cfdb-497d-8df7-37ec791ea717 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LightWalker ST-E ADVANCED |
Version Model Number | M002-6A/2 ADVANCED |
Company DUNS | 644720625 |
Company Name | FOTONA d.o.o. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03830054230347 [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 | 2017-05-30 |
03830054230897 | The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invi |
03830054230347 | The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invi |