VisiCORE
GUDID 00850008316142
VisiCORE Bone Harvester, 8mm
PARADIGM BIODEVICES INC
Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable Bone trephine, reusable| 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 |
Customer Support Contacts
Device Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850008316142 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-09 |
| Device Publish Date | 2023-11-01 |
Devices Manufactured by PARADIGM BIODEVICES INC
| 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 |
Trademark Results [VisiCORE]
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 |
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