| Primary Device ID | 00850064466058 |
| NIH Device Record Key | 5f8a9e4b-2d7f-4a0a-befc-0732419e3d89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blunt Tip Microcannula Slim Fabinject 21G70MM |
| Version Model Number | BTC21G070UOU |
| Company DUNS | 032329574 |
| Company Name | FABINJECT LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com | |
| Phone | (321)972-4528 |
| fabinjectllc_regulatory@outlook.com |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850064466058 [Primary] |
| GEA | Cannula, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-21 |
| Device Publish Date | 2024-08-13 |
| 00850064466188 - Blunt Tip Microcannula Slim Fabinject 22G50MM | 2025-03-10 Blunt Tip Microcannula Slim Fabinject 22G 50 mm, single use sterile pack with pilot needle - box with 10 units |
| 00850064466027 - FREDDO | 2024-11-05 Skin cooling device |
| 00850064466249 - Duck-bill Tip Microcannula Slim Fabinject 15G100MM | 2024-08-22 Duck-bill Tip Microcannula Slim Fabinject 15G100MM, packed with punch needle - box with 10 units |
| 00850064466256 - Duck-bill Tip Microcannula Slim Fabinject 20G70MM | 2024-08-22 Duck-bill Tip Microcannula Slim Fabinject 20G70MM, packed with punch needle - box with 10 units |
| 00850064466034 - Blunt Tip Microcannula Slim Fabinject 20G100MM | 2024-08-21 Blunt Tip Microcannula Slim Fabinject 20G100MM single unit packaged in sterile blister pack |
| 00850064466041 - Blunt Tip Microcannula Slim Fabinject 21G50MM | 2024-08-21 Blunt Tip Microcannula Slim Fabinject 21G50MM single unit packaged in sterile blister pack |
| 00850064466058 - Blunt Tip Microcannula Slim Fabinject 21G70MM | 2024-08-21Blunt Tip Microcannula Slim Fabinject 21G70MM single unit packaged in sterile blister pack |
| 00850064466058 - Blunt Tip Microcannula Slim Fabinject 21G70MM | 2024-08-21 Blunt Tip Microcannula Slim Fabinject 21G70MM single unit packaged in sterile blister pack |
| 00850064466065 - Blunt Tip Microcannula Slim Fabinject 22G50MM | 2024-08-21 Blunt Tip Microcannula Slim Fabinject 22G50MM single unit packaged in sterile blister pack |