| Primary Device ID | 03700879518466 | 
| NIH Device Record Key | ecec0a24-40a3-4d3e-b212-849ba3889b8c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | XSD11001 | 
| Catalog Number | XSD11001 | 
| 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 | true | 
| 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 | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | |
| Phone | +33299338650 | 
| contact@novastep-ortho.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 03700879518466 [Primary] | 
| FZX | Guide, Surgical, Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
[03700879518466]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-09-30 | 
| Device Publish Date | 2025-09-22 | 
| 03700879518039 - NA | 2025-09-30 Threaded shouldered pin Ø2.5 lg 72 | 
| 03700879518046 - NA | 2025-09-30 Threaded shouldered pin Ø2.5 lg 72 - sterile | 
| 03700879518138 - NA | 2025-09-30 Cutting guide frame | 
| 03700879518145 - NA | 2025-09-30 Calca slide centering window | 
| 03700879518169 - NA | 2025-09-30 Calca slide cutting window | 
| 03700879518190 - NA | 2025-09-30 Translation tool | 
| 03700879518206 - NA | 2025-09-30 Threaded shouldered pin Ø3.5 lg 85 | 
| 03700879518213 - NA | 2025-09-30 Threaded shouldered pin Ø3.5 lg 85 - sterile |