Primary Device ID | 08800020102010 |
NIH Device Record Key | ca0c1f7f-3237-401c-9263-1154329e8023 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tri-Beam Nd:YAG Laser System |
Version Model Number | TRI-BEAM |
Company DUNS | 690275362 |
Company Name | Jeisys Medical 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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800020102010 [Primary] |
GS1 | 8800020102034 [Package] Package: Wooden crate [1 Units] In Commercial Distribution |
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 | 2021-08-24 |
Device Publish Date | 2016-10-31 |
18800020105506 - POTENZA Tip | 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-25 Tip) |
18800020105612 - POTENZA Tip | 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-16 Tip) |
18800020105629 - POTENZA Tip | 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-49 Tip) |
18800020106299 - POTENZA Tip | 2025-05-27 POTENZA Tip (DDR Tip) |
08800020106308 - POTENZA Tip | 2025-05-27 POTENZA Tip (SFA Tip) |
18800020106312 - POTENZA Tip | 2025-05-27 POTENZA Tip (DIA Tip) |
08800020103536 - DENZA Main body | 2023-09-06 Radio-frequency skin contouring system |
08800020103918 - DENZA B-Tip II | 2023-09-06 DENZA B-Tip II |