| Primary Device ID | 09120034306976 |
| NIH Device Record Key | b3f33d04-337c-42e6-9f4c-e859c879fe5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cortical Screw, Locking |
| Version Model Number | 37455-65 |
| Catalog Number | 37455-65 |
| Company DUNS | 303456917 |
| Company Name | I.T.S. GmbH |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 09120034306976 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
[09120034306976]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-08-07 |
| Device Publish Date | 2016-09-08 |
| 09120069812770 | Cortical Screw, Locking, D=3.5mm, L=120mm, SH |
| 09120069812763 | Cortical Screw, Locking, D=3.5mm, L=115mm, SH |
| 09120069812756 | Cortical Screw, Locking, D=3.5mm, L=110mm, SH |
| 09120069812749 | Cortical Screw, Locking, D=3.5mm, L=105mm, SH |
| 09120069812732 | Cortical Screw, Locking, D=3.5mm, L=100mm, SH |
| 09120069812725 | Cortical Screw, Locking, D=3.5mm, L=95mm, SH |
| 09120069812718 | Cortical Screw, Locking, D=3.5mm, L=90mm, SH |
| 09120069812701 | Cortical Screw, Locking, D=3.5mm, L=85mm, SH |
| 09120069812695 | Cortical Screw, Locking, D=3.5mm, L=80mm, SH |
| 09120069812688 | Cortical Screw, Locking, D=3.5mm, L=75mm, SH |
| 09120069812671 | Cortical Screw, Locking, D=3.5mm, L=70mm, SH |
| 09120069812664 | Cortical Screw, Locking, D=3.5mm, L=65mm, SH |
| 09120069812657 | Cortical Screw, Locking, D=3.5mm, L=60mm, SH |
| 09120069812640 | Cortical Screw, Locking, D=3.5mm, L=55mm, SH |
| 09120069812633 | Cortical Screw, Locking, D=3.5mm, L=50mm, SH |
| 09120069812626 | Cortical Screw, Locking, D=3.5mm, L=48mm, SH |
| 09120069812619 | Cortical Screw, Locking, D=3.5mm, L=46mm, SH |
| 09120069812602 | Cortical Screw, Locking, D=3.5mm, L=44mm, SH |
| 09120069812596 | Cortical Screw, Locking, D=3.5mm, L=42mm, SH |
| 09120069811896 | Cortical Screw, Locking, D=3.5mm, L=10mm, SH |
| 09120047297933 | Cortical Screw, Locking, D=3.5mm, L=38mm, SH |
| 09120047297926 | Cortical Screw, Locking, D=3.5mm, L=26mm, SH |
| 09120047297919 | Cortical Screw, Locking, D=3.5mm, L=34mm, SH |
| 09120047295236 | Cortical Screw, Locking, D=3.5mm, L=22mm, SH |
| 09120047295229 | Cortical Screw, Locking, D=3.5mm, L=20mm, SH |
| 09120047295212 | Cortical Screw, Locking, D=3.5mm, L=18mm, SH |
| 09120047295205 | Cortical Screw, Locking, D=3.5mm, L=16mm, SH |
| 09120047295199 | Cortical Screw, Locking, D=3.5mm, L=14mm, SH |
| 09120047295182 | Cortical Screw, Locking, D=3.5mm, L=12mm, SH |
| 09120034307966 | Cortical Screw, Locking, D=3.5mm, L=30mm, SH |
| 09120034307201 | Cortical Screw, Locking, D=4.5mm, L=120mm |
| 09120034307195 | Cortical Screw, Locking, D=4.5mm, L=115mm |
| 09120034307188 | Cortical Screw, Locking, D=4.5mm, L=110mm |
| 09120034307171 | Cortical Screw, Locking, D=4.5mm, L=105mm |
| 09120034307164 | Cortical Screw, Locking, D=4.5mm, L=100mm |
| 09120034307157 | Cortical Screw, Locking, D=4.5mm, L=95mm |
| 09120034307027 | Cortical Screw, Locking, D=4.5mm, L=90mm |
| 09120034307010 | Cortical Screw, Locking, D=4.5mm, L=85mm |
| 09120034307003 | Cortical Screw, Locking, D=4.5mm, L=80mm |
| 09120034306990 | Cortical Screw, Locking, D=4.5mm, L=75mm |
| 09120034306983 | Cortical Screw, Locking, D=4.5mm, L=70mm |
| 09120034306976 | Cortical Screw, Locking, D=4.5mm, L=65mm |
| 09120034306969 | Cortical Screw, Locking, D=4.5mm, L=60mm |
| 09120034306952 | Cortical Screw, Locking, D=4.5mm, L=56mm |
| 09120034306945 | Cortical Screw, Locking, D=4.5mm, L=52mm |
| 09120034306938 | Cortical Screw, Locking, D=4.5mm, L=48mm |
| 09120034306921 | Cortical Screw, Locking, D=4.5mm, L=44mm |
| 09120034306914 | Cortical Screw, Locking, D=4.5mm, L=40mm |
| 09120034306907 | Cortical Screw, Locking, D=4.5mm, L=36mm |
| 09120034306891 | Cortical Screw, Locking, D=4.5mm, L=32mm |