| Primary Device ID | 03700879518374 |
| NIH Device Record Key | 851125e3-ae81-435d-9200-40784c3851c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ACC1024P0002 |
| Catalog Number | ACC1024P0002 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700879518374 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
Moist Heat or Steam Sterilization
[03700879518374]
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 |
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| 03700879515182 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg24 |
| 03700879515199 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg26 |
| 03700879515205 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg28 |
| 03700879515212 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg30 |
| 03700879515229 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg32 |