| Primary Device ID | 03613720295624 |
| NIH Device Record Key | 6fc2388f-78c3-4eab-b4b8-606fe56135d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PASS LP PASS TL |
| Version Model Number | B22110001 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| 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 | 03613720295624 [Primary] |
| NKB | Thoracolumbosacral pedicle screw system |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
[03613720295624]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-01 |
| Device Publish Date | 2024-07-24 |
| 03613720295631 | HOOK B22110008 TP 0-8 |
| 03613720295624 | SET SCREW B22110001 FOR HOOK |
| 03613720295747 | HOOK B22120008 PEDICLE 0-8 |
| 03613720295730 | HOOK B22120006 PEDICLE 0-6.5 |
| 03613720295723 | HOOK B22120005 PEDICLE 0-5 |
| 03613720295716 | HOOK B22111510R RIGHT TP 15-10 |
| 03613720295709 | HOOK B22111510L LEFT TP 15-10 |
| 03613720295693 | HOOK B22111509R RIGHT TP 15-9 |
| 03613720295686 | HOOK B22111509L LEFT TP 15-9 |
| 03613720295679 | HOOK B22111508R RIGHT TP 15-8 |
| 03613720295662 | HOOK B22111508L LEFT TP 15-8 |
| 03613720295655 | HOOK B22110010 TP 0-10 |
| 03613720295648 | HOOK B22110009 TP 0-9 |