| Primary Device ID | 03613720293828 |
| NIH Device Record Key | 8bb28233-8438-4d87-998d-5d56d7708133 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PASS SPINAL SYSTEM |
| Version Model Number | B02150005 |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720293828 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
Moist Heat or Steam Sterilization
[03613720293828]
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 |
| 03613720286714 - IB3D™ PL Spinal System | 2025-03-04 PUSHER A24000230 IB3D IMPLANT PUSHER |
| 03613720286677 - IB3D™ PL Spinal System | 2025-03-03 INSERTER A24000000 IB3D IMPLANT |
| 03613720286684 - IB3D™ PL Spinal System | 2025-03-03 SLAPHAMMER A24000200 IB3D SLAP HAMMER |
| 03613720286707 - IB3D™ PL Spinal System | 2025-03-03 REMOVER A24000220 IB3D IMPLANT REMOVER |
| 03613720286202 - IB3D™ PL Spinal System | 2025-02-24 CAGE B241C08062209 3D PL 8X6DGX22X9MM |
| 03613720286219 - IB3D™ PL Spinal System | 2025-02-24 CAGE B241C09062209 3D PL 9X6DGX22X9MM |
| 03613720286226 - IB3D™ PL Spinal System | 2025-02-24 CAGE B241C10062209 3D PL 10X6DGX22X9MM |
| 03613720286233 - IB3D™ PL Spinal System | 2025-02-24 CAGE B241C11062209 3D PL 11X6DGX22X9MM |