| Primary Device ID | 00850008316142 |
| NIH Device Record Key | 37863e5a-505c-4ebb-bd4f-f2925d40c4f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VisiCORE |
| Version Model Number | 988-0800SK |
| Company DUNS | 170751924 |
| Company Name | PARADIGM BIODEVICES INC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850008316142 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-09 |
| Device Publish Date | 2023-11-01 |
| 00850008316142 - VisiCORE | 2023-11-09VisiCORE Bone Harvester, 8mm |
| 00850008316142 - VisiCORE | 2023-11-09 VisiCORE Bone Harvester, 8mm |
| 30850008316013 - QuickDraw | 2019-07-09 QuickDraw Bone Harvester, 12mm |
| 30850008316020 - QuickDraw | 2019-07-09 QuickDraw Bone Harvester, 10mm |
| 30850008316037 - QuickDraw | 2019-07-09 QuickDraw Bone Harvester, 10mm short |
| 00850008316050 - QuickDraw | 2019-07-09 QuickDraw Bone Harvester MIS Kit, 10mm short |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISICORE 98177257 not registered Live/Pending |
ONeill, Michael 2023-09-13 |
![]() VISICORE 85957672 4470348 Live/Registered |
VisiCore Technology Group, LLC 2013-06-12 |