| Primary Device ID | B104CP0350 |
| NIH Device Record Key | 8f107149-7ccd-4567-b2fe-d1d8ce92a2a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Emerald Cervical PEEK |
| Version Model Number | C-P-035 |
| Catalog Number | C-P-035 |
| Company DUNS | 066151033 |
| Company Name | GLASIR MEDICAL LP |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B104CP0350 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B104CP0350]
Moist Heat or Steam Sterilization
[B104CP0350]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2017-04-05 |
| B104CP0370 | 12mm Emerald Parallel Cervical PEEK |
| B104CP0360 | 11mm Emerald Parallel Cervical PEEK |
| B104CP0350 | 10mm Emerald Parallel Cervical PEEK |
| B104CP0340 | 9mm Emerald Parallel Cervical PEEK |
| B104CP0330 | 8mm Emerald Parallel Cervical PEEK |
| B104CP0320 | 7mm Emerald Parallel Cervical PEEK |
| B104CP0310 | 6mm Emerald Parallel Cervical PEEK |
| B104CP0300 | 5mm Emerald Parallel Cervical PEEK |
| B104CL0370 | 12mm Emerald Lordotic Cervical PEEK |
| B104CL0360 | 11mm Emerald Lordotic Cervical PEEK |
| B104CL0350 | 10mm Emerald Lordotic Cervical PEEK |
| B104CL0340 | 9mm Emerald Lordotic Cervical PEEK |
| B104CL0330 | 8mm Emerald Lordotic Cervical PEEK |
| B104CL0320 | 7mm Emerald Lordotic Cervical PEEK |
| B104CL0310 | 6mm Emerald Lordotic Cervical PEEK |