| Primary Device ID | M719GCP2AV40160 |
| NIH Device Record Key | d92ebe84-08b5-4788-8977-c5b304849ae7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anterior Cervical Plate |
| Version Model Number | 1 |
| Catalog Number | GCP2-AV4016 |
| Company DUNS | 017921066 |
| Company Name | Genesys Orthopedics Systems LLC |
| 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 | 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 |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719GCP2AV40160 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
[M719GCP2AV40160]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-28 |
| Device Publish Date | 2023-07-20 |
| M719GCP4030 | 4-Sided Ratchet AO Connect |
| M719GCP2AV40180 | 4.00mm x 18mm Binary Auger Tip Variable Screw |
| M719GCP2AV40160 | 4.00mm x 16mm Binary Auger Tip Variable Screw |
| M719GCP2AV40140 | 4.00mm x 14mm Binary Auger Tip Variable Screw |
| M719GCP2AV40120 | 4.00mm x 12mm Binary Auger Tip Variable Screw |
| M719GCP2AV40100 | 4.00mm x 10mm Binary Auger Tip Variable Screw |
| M719GCP23430 | 43mm 3-Level Binary Cervical Plate |
| M719GCP23400 | 40mm 3-Level Binary Cervical Plate |
| M719GCP23370 | 37mm 3-Level Binary Cervical Plate |
| M719GCP22240 | 24mm 2-Level Binary Cervical Plate |