| Primary Device ID | 03700879509082 |
| NIH Device Record Key | f0d241f2-8fa6-4196-ab34-a98273e52f12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | nexis/arcad® |
| Version Model Number | ACC1001P0016 |
| Catalog Number | ACC1001P0016 |
| 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 | false |
| Serial Number | true |
| 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 | +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 | |
| 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 | 03700879509082 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
[03700879509082]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
| 03700879517940 - PECA®2.0 | 2025-11-21 Tray |
| 03700879517957 - PECA®2.0 | 2025-11-21 Lid |
| 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 |