| Primary Device ID | 00810076333441 |
| NIH Device Record Key | ac68e301-91eb-408f-b225-e26944617d3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Momentum MIS |
| Version Model Number | UU091-55-5170 |
| Company DUNS | 624083866 |
| Company Name | Ulrich Medical Usa, 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 | 00810076333441 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
[00810076333441]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-21 |
| Device Publish Date | 2024-03-13 |
| 00810076337517 | Rod inserter locking handle |
| 00810076337470 | Rod, Ø 6.0mm, length 85mm, curved, titanium |
| 00810076337463 | Rod, Ø 6.0mm, length 75mm, curved, titanium |
| 00810076337456 | Rod, Ø 6.0mm, length 65mm, curved, titanium |
| 00810076337449 | Rod, Ø 5.5mm, length 85mm, curved, titanium |
| 00810076337432 | Rod, Ø 5.5mm, length 75mm, curved, titanium |
| 00810076337425 | Rod, Ø 5.5mm, length 65mm, curved, titanium |
| 00810076337500 | MIS Screw head adjuster, 1/4" square |
| 00810076337067 | Dilator, Medium, PPSU |
| 00810076335148 | Tab retaining ring |
| 00810076335124 | Sterilization case, Iliac |
| 00810076334349 | Sterilization case, instrument module #2, top level |
| 00810076334332 | Sterilization case, instrument module #2, outer case |
| 00810076334325 | Sterilization case, instrument module #1, outer case |
| 00810076334318 | Sterilization case, implants, outer case |
| 00810076334301 | Iliac Tap, dia. 10.0mm, cannulated, 1/4" square |
| 00810076334295 | Iliac Tap, dia. 9.0mm, cannulated, 1/4" square |
| 00810076334288 | Iliac Tap, dia. 8.0mm, cannulated, 1/4" square |
| 00810076334271 | Iliac Tap, dia. 7.0mm, cannulated, 1/4" square |
| 00810076334264 | Iliac Dilator, Medium |
| 00810076334257 | Iliac Dilator, Small |
| 00810076334240 | Rod Inserter, 5.5/6.0mm, curved |
| 00810076334080 | MIS Iliac Screw, polyaxial, dia 9mm, length 110mm, open, cannulated |
| 00810076334073 | MIS Iliac Screw, polyaxial, dia 9mm, length 100mm, open, cannulated |
| 00810076334066 | MIS Iliac Screw, polyaxial, dia 9mm, length 90mm, open, cannulated |
| 00810076334059 | MIS Iliac Screw, polyaxial, dia 9mm, length 80mm, open, cannulated |
| 00810076334042 | MIS Iliac Screw, polyaxial, dia 9mm, length 70mm, open, cannulated |
| 00810076334035 | MIS Iliac Screw, polyaxial, dia 8mm, length 110mm, open, cannulated |
| 00810076334028 | MIS Iliac Screw, polyaxial, dia 8mm, length 100mm, open, cannulated |
| 00810076334011 | MIS Iliac Screw, polyaxial, dia 8mm, length 90mm, open, cannulated |
| 00810076334004 | MIS Iliac Screw, polyaxial, dia 8mm, length 80mm, open, cannulated |
| 00810076333991 | MIS Iliac Screw, polyaxial, dia 8mm, length 70mm, open, cannulated |
| 00810076333984 | MIS Iliac Screw, polyaxial, dia 10mm, length 110mm, open, cannulated |
| 00810076333977 | MIS Iliac Screw, polyaxial, dia 10mm, length 100mm, open, cannulated |
| 00810076333960 | MIS Iliac Screw, polyaxial, dia 10mm, length 90mm, open, cannulated |
| 00810076333953 | MIS Iliac Screw, polyaxial, dia 10mm, length 80mm, open, cannulated |
| 00810076333946 | MIS Iliac Screw, polyaxial, dia 10mm, length 70mm, open, cannulated |
| 00810076333939 | Screwdriver for locking screw, SR25, self-retaining |
| 00810076333922 | Counter-torque, wrench |
| 00810076333854 | Star knob |
| 00810076333731 | Locking handle, guidewire lock |
| 00810076333724 | Threaded shank, guidewire lock |
| 00810076333717 | Rod, dia. 6mm, length 200mm, straight, percutaneous approach |
| 00810076333700 | Rod, dia. 6mm, length 190mm, straight, percutaneous approach |
| 00810076333694 | Rod, dia. 6mm, length 180mm, straight, percutaneous approach |
| 00810076333687 | Rod, dia. 6mm, length 170mm, straight, percutaneous approach |
| 00810076333670 | Rod, dia. 6mm, length 160mm, straight, percutaneous approach |
| 00810076333663 | Rod, dia. 6mm, length 150mm, straight, percutaneous approach |
| 00810076333656 | Rod, dia. 6mm, length 140mm, straight, percutaneous approach |
| 00810076333649 | Rod, dia. 6mm, length 130mm, straight, percutaneous approach |