| Primary Device ID | M719GCP24880 |
| NIH Device Record Key | b85818c3-6176-4696-a961-4f8316627b89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Binary |
| Version Model Number | 1 |
| Catalog Number | GCP2-488 |
| Company DUNS | 017921066 |
| Company Name | Genesys Orthopedics Systems LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | 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 |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Length | 88 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719GCP24880 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
[M719GCP24880]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2015-08-31 |
| M719GCP2AV4220 | 4.25mm x 22mm Binary Auger Tip Variable Screw |
| M719GCP2AV4200 | 4.25mm x 20mm Binary Auger Tip Variable Screw |
| M719GCP2AV40220 | 4.0mm x 22mm Binary Auger Tip Variable Screw |
| M719GCP2AV40200 | 4.0mm x 20mm Binary Auger Tip Variable Screw |
| M719GCP2AV3220 | 3.75mm x 22mm Binary Auger Tip Variable Screw |
| M719GCP2AV3200 | 3.75mm x 20mm Binary Auger Tip Variable Screw |
| M719GCP2AF4220 | 4.25mm x 22mm Binary Auger Tip Fixed Screw |
| M719GCP2AF4200 | 4.25mm x 20mm Binary Auger Tip Fixed Screw |
| M719GCP2AF40220 | 4.0mm x 22mm Binary Auger Tip Fixed Screw |
| M719GCP2AF40200 | 4.0mm x 22mm Binary Auger Tip Fixed Screw |
| M719GCP2AF3220 | 3.75mm x 22mm Binary Auger Tip Fixed Screw |
| M719GCP2AF3200 | 3.75mm x 20mm Binary Auger Tip Fixed Screw |
| M719GP7040 | Fixed AO Straight Handle |
| M719GCP4020 | Mini 4-Sided Ratchet AO Connect Jewelers Knob Handle |
| M719GCP4010 | Mini 4-Sided Ratchet AO Connect Handle |
| M719GCP4000 | Mini 4-Sided Fixed AO Connect Handle |
| M719GCP2AV4180 | Binary Auger Tip Variable Screw |
| M719GCP2AV4160 | Binary Auger Tip Variable Screw |
| M719GCP2AV4140 | Binary Auger Tip Variable Screw |
| M719GCP2AV4120 | Binary Auger Tip Variable Screw |
| M719GCP2AV4100 | Binary Auger Tip Variable Screw |
| M719GCP2AV3180 | Binary Auger Tip Variable Screw |
| M719GCP2AV3160 | Binary Auger Tip Variable Screw |
| M719GCP2AV3140 | Binary Auger Tip Variable Screw |
| M719GCP2AV3120 | Binary Auger Tip Variable Screw |
| M719GCP2AV3100 | Binary Auger Tip Variable Screw |
| M719GCP2AF4180 | Binary Auger Tip Fixed Screw |
| M719GCP2AF4160 | Binary Auger Tip Fixed Screw |
| M719GCP2AF4140 | Binary Auger Tip Fixed Screw |
| M719GCP2AF4120 | Binary Auger Tip Fixed Screw |
| M719GCP2AF4100 | Binary Auger Tip Fixed Screw |
| M719GCP2AF3180 | Binary Auger Tip Fixed Screw |
| M719GCP2AF3160 | Binary Auger Tip Fixed Screw |
| M719GCP2AF3140 | Binary Auger Tip Fixed Screw |
| M719GCP2AF3120 | Binary Auger Tip Fixed Screw |
| M719GCP2AF3100 | Binary Auger Tip Fixed Screw |
| M719GCP2500 | Binary Fixed Single Drill Guide, Short |
| M719GCP24920 | 4-Level Binary Cervical Plate |
| M719GCP2490 | Binary 12mm Awl For Fixed Guide |
| M719GCP24880 | 4-Level Binary Cervical Plate |
| M719GCP24840 | 4-Level Binary Cervical Plate |
| M719GCP24800 | 4-Level Binary Cervical Plate |
| M719GCP2480 | Binary Fixed Drill Guide, Short |
| M719GCP24760 | 4-Level Binary Cervical Plate |
| M719GCP24720 | 4-Level Binary Cervical Plate |
| M719GCP24680 | 4-Level Binary Cervical Plate |
| M719GCP24640 | 4-Level Binary Cervical Plate |
| M719GCP24600 | 4-Level Binary Cervical Plate |
| M719GCP2460 | Cervical Friction Star Driver |
| M719GCP2450 | Cervical Bone Compass |
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Wirepath Home Systems, LLC 2016-04-15 |
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Genesys Orthopedic Systems, LLC 2015-01-08 |
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Yikwang Jonathan Teo 2014-03-28 |
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BOWTECH, INC. 2013-01-15 |
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Vectura Delivery Devices Limited 2004-04-29 |
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Helena Chemical Company 2002-07-15 |
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Smith International, Inc. 2002-01-11 |