| Primary Device ID | 03700879518220 |
| NIH Device Record Key | 6492747f-38ba-4f23-8884-1a977f61d550 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CRE23030 |
| Catalog Number | CRE23030 |
| Company DUNS | 264255288 |
| Company Name | NOVASTEP |
| 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 | true |
| Expiration Date | true |
| 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 | 03700879518220 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2025-09-22 |
| 03700879515151 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg18 |
| 03700879515168 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg20 |
| 03700879515175 - PECA®2.0 | 2025-12-15 Beveled compressive implant Ø4 lg22 |
| 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 |