| Primary Device ID | 00894743001376 |
| NIH Device Record Key | 71bfd069-c714-4f33-bc6e-97d681dd2517 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Facet Medcial Technologies |
| Version Model Number | 0110002 |
| Catalog Number | 0110002 |
| Company DUNS | 130518376 |
| Company Name | FACET TECHNOLOGIES, LLC |
| Device Count | 100 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
| Phone | 770-590-6462 |
| jbonds@facetmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894743001376 [Primary] |
| GS1 | 10894743001373 [Unit of Use] |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2020-04-29 |
| 00894743001338 - Facet Medical Technologies | 2020-10-05 FMT Lancer Kit, CE |
| 00894743001345 - Facet Medical Technologies | 2020-10-05 FMT Lancer |
| 00894743001369 - Facet Medical Technologies | 2020-05-07 FMT Lancets, 30G |
| 00894743001376 - Facet Medcial Technologies | 2020-05-07FMT Lancets, 33G |
| 00894743001376 - Facet Medcial Technologies | 2020-05-07 FMT Lancets, 33G |
| 00894743001017 - SureSeal | 2019-07-10 SureSeal Pressure Bandage, 25mm x 72mm |
| 00894743001024 - SureSeal | 2019-07-10 SureSeal Pressure Bandage, 30mm x 72mm |
| 00894743001000 - CAREFINE | 2019-07-03 CareFine with Quintapoint Pen Needles - 6mm x 32G |
| 00894743001147 - CAREFINE | 2019-07-03 CareFine with Quintapoint Pen Needles - 6mm x 32G - Mail Order |