| Primary Device ID | 10850005165573 |
| NIH Device Record Key | b3215936-20cd-44b0-99a4-09c394bbc106 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotroix Healthcare Syringes |
| Version Model Number | GE12010S |
| Catalog Number | GE12010S |
| Company DUNS | 065762392 |
| Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005165576 [Primary] |
| GS1 | 10850005165573 [Package] Contains: 00850005165576 Package: INNER BOX [100 Units] In Commercial Distribution |
| GS1 | 20850005165570 [Package] Package: CASE [10 Units] In Commercial Distribution |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 10850005165573 - Biotroix Healthcare Syringes | 2024-03-19Syringe 1cc Luer Lock without needle, Each |
| 10850005165573 - Biotroix Healthcare Syringes | 2024-03-19 Syringe 1cc Luer Lock without needle, Each |
| 10850005165290 - Biotronix Healthcare Suture Removal Tray | 2021-02-08 Suture Removal Tray |
| 10850005165009 - Biotronix Healthcare Foley Trays | 2019-12-24 Pre-Connected Latex Foley Tray 18FR |
| 10850005165016 - Biotronix Healthcare Urethral Catheter Trays | 2019-12-24 Intermittent Urethral Catheter Tray 14FR, PVC |
| 10850005165023 - Biotronix Healthcare Enema Bag Set | 2019-12-24 Enema Bag Set |
| 10850005165030 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Bulb Syringe |
| 10850005165047 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Piston Syringe |
| 10850005165054 - Biotronix Healthcare | 2019-12-24 Minor Laceration Tray w/ Instrument |