| Primary Device ID | 08800089425952 |
| NIH Device Record Key | d2bd9edc-910a-4ac3-b63e-e8b453b1fa13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIX-C PEEK Anterior Cervical Interbody System |
| Version Model Number | SC1-PCGS-08 |
| Company DUNS | 688811603 |
| Company Name | Jeil Medical Corporation |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08800089425952 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
[08800089425952]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-19 |
| Device Publish Date | 2022-01-11 |