| Primary Device ID | 03700879512334 |
| NIH Device Record Key | a98ae84c-3725-48e4-9203-850236f76582 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIRLOCK Centrolock |
| Version Model Number | XPP01005 |
| Catalog Number | XPP01005 |
| Company DUNS | 264255288 |
| Company Name | NOVASTEP |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| 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 | 03700879512334 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
[03700879512334]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-10 |
| Device Publish Date | 2020-01-02 |
| 03700879512532 | Centrolock implant trial holder |
| 03700879512525 | Centrolock Lid |
| 03700879512518 | Centrolock Tray |
| 03700879512501 | Centrolock temporary fixation pin - Single use |
| 03700879512464 | Centrolock K-wires holder |
| 03700879512457 | Centrolock countersink |
| 03700879512440 | Centrolock depth gauge |
| 03700879512341 | Centrolock countersink Single use |
| 03700879512334 | Centrolock temporary fixation pin |
| 03700879512327 | CENTROLOCK cortical screw Ø2 length 24 |
| 03700879512310 | Airlock Centrolock Locking screw Ø2,5 length 26 |
| 03700879512303 | Airlock Centrolock Locking screw Ø2,5 length 24 |
| 03700879512044 | Centrolock drill bit Ø1.8 Single use |
| 03700879512037 | Centrolock drill bit Ø1.5 Single use |
| 03700879512020 | CENTROLOCK cortical screw Ø2 length 22 |
| 03700879512013 | CENTROLOCK cortical screw Ø2 length 20 |
| 03700879512006 | CENTROLOCK cortical screw Ø2 length 18 |
| 03700879511993 | CENTROLOCK cortical screw Ø2 length 16 |
| 03700879511986 | CENTROLOCK cortical screw Ø2 length 14 |
| 03700879511979 | CENTROLOCK cortical screw Ø2 length 12 |
| 03700879511962 | Airlock Centrolock Locking screw Ø2,5 length 22 |
| 03700879511955 | Airlock Centrolock Locking screw Ø2,5 length 20 |
| 03700879511948 | Airlock Centrolock Locking screw Ø2,5 length 18 |
| 03700879511931 | Airlock Centrolock Locking screw Ø2,5 length 16 |
| 03700879511924 | Airlock Centrolock Locking screw Ø2,5 length 14 |
| 03700879511917 | Airlock Centrolock Locking screw Ø2,5 length 12 |
| 03700879511900 | Airlock Centrolock Locking screw Ø2,5 length 10 |
| 03700879511894 | Airlock Centrolock Locking screw Ø2,5 length 8 |
| 03700879511887 | CENTROLOCK implant - Right step 6mm |
| 03700879511870 | CENTROLOCK implant - Right step 4mm |
| 03700879511863 | CENTROLOCK implant - Right step 2mm |
| 03700879511856 | CENTROLOCK implant - Left step 6mm |
| 03700879511849 | CENTROLOCK implant - Left step 4mm |
| 03700879511832 | CENTROLOCK implant - Left step 2mm |
| 03700879511825 | Centrolock trial implant - Right step 6mm |
| 03700879511818 | Centrolock trial implant - Right step 4mm |
| 03700879511801 | Centrolock trial implant - Right step 2mm |
| 03700879511795 | Centrolock trial implant - Left step 6mm |
| 03700879511788 | Centrolock trial implant - Left step 4mm |
| 03700879511771 | Centrolock trial implant - Left step 2mm |
| 03700879511757 | Centrolock impactor |
| 03700879511740 | Centrolock screwdriver tip T7 |
| 03700879511733 | Centrolock drill bit Ø1.8 |
| 03700879511726 | Centrolock drill bit Ø1.5 |
| 03700879511719 | Centrolock drill guide - screw Ø2,5 |
| 03700879511702 | Centrolock drill guide - screw Ø2 |
| 03700879511696 | Centrolock targeting / compressing guide |
| 03700879511689 | Centrolock cannulated reamer |
| 03700879511672 | Centrolock elevator |
| 03700879511665 | Centrolock cutting guide |