| Primary Device ID | M896PRCSAP1201 |
| NIH Device Record Key | 50804903-fedd-4b35-8cc1-d38006bdfe5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precise Sapphire |
| Version Model Number | PRC-SAP-120 |
| Company DUNS | 809012870 |
| Company Name | ARTERIOCYTE MEDICAL SYSTEMS, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896PRCSAP1200 [Primary] |
| HIBCC | M896PRCSAP1201 [Package] Contains: M896PRCSAP1200 Package: [5 Units] In Commercial Distribution |
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-07 |
| Device Publish Date | 2023-05-30 |
| M896IFLXMAX020 - Magellan Influx | 2023-06-14 MAR0 Kit with 2.5cc Influx Max |
| M896AMS500220500 - Precise | 2023-06-07 Precise Separation Canister, 60 mL |
| M896AMS500220530 - Precise | 2023-06-07 Precise Separation Canister, 60mL |
| M896AMS500220560 - Precise | 2023-06-07 Precise Separation Canister, 60 mL |
| M896AMS500350500 - Precise | 2023-06-07 Precise Separation Canister, 120 mL |
| M896AMS500350530 - Precise | 2023-06-07 Precise Separation Canister, 120 mL |
| M896AMS500350560 - Precise | 2023-06-07 Precise Separation Canister, 120 mL |
| M896PRCDIA0600 - Precise Diamond | 2023-06-07 Precise Diamond - 60 mL LP Kit |