| Primary Device ID | 00860004198833 |
| NIH Device Record Key | 7515164c-a426-47ca-ac3c-d7496cdd79d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Permablate |
| Version Model Number | PEU-K01 |
| Catalog Number | PEU-K01 |
| Company DUNS | 865757421 |
| Company Name | GMMI SDN. BHD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com | |
| Phone | +6053131912 |
| nicole.leow@gmmi-med.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004198826 [Primary] |
| GS1 | 00860004198833 [Package] Contains: 00860004198826 Package: Carton [32 Units] In Commercial Distribution |
| HPY | Unit, Electrolysis, Battery-Powered, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-11-13 |
| 10860004198854 - SüpeVac – Portable Single Use Hand-Held Suction Device | 2025-06-02 |
| 10860004198861 - Stylet – Tracheal Tube/ Bougie Catheter | 2025-06-02 |
| 00860004198833 - Permablate | 2020-12-21Permablate Electrolysis Unit |
| 00860004198833 - Permablate | 2020-12-21 Permablate Electrolysis Unit |
| 10860004198809 - Stylet – Tracheal Tube/ Bougie Catheter | 2020-12-09 |