| Primary Device ID | 10860004198809 |
| NIH Device Record Key | e2cde0e8-0a52-4732-9070-9babe9d12123 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stylet – Tracheal Tube/ Bougie Catheter |
| Version Model Number | CM001 |
| Catalog Number | CM001 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004198802 [Primary] |
| GS1 | 10860004198809 [Package] Contains: 00860004198802 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 20860004198806 [Package] Package: Carton [30 Units] In Commercial Distribution |
| BSR | Stylet, Tracheal Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-12-09 |
| Device Publish Date | 2020-06-08 |
| 00860004198833 - Permablate | 2020-12-21 Permablate Electrolysis Unit |
| 10860004198809 - Stylet – Tracheal Tube/ Bougie Catheter | 2020-12-09 |
| 10860004198809 - Stylet – Tracheal Tube/ Bougie Catheter | 2020-12-09 |