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 |