| Primary Device ID | 00815101026404 |
| NIH Device Record Key | e99bda7d-56f2-4edd-9c0a-6a41e25e0b24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PCT |
| Version Model Number | PCT0335100 |
| Company DUNS | 949024850 |
| Company Name | Centinel Spine, Inc. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00815101026404 [Primary] |
| NKG | Orthosis, Cervical Pedicle Screw Spinal Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
[00815101026404]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-06 |