| Primary Device ID | 03700879517940 |
| NIH Device Record Key | d6f93bcf-a00d-4d99-90bf-7851d26e41df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PECA®2.0 |
| Version Model Number | ACC1023P0001 |
| Catalog Number | ACC1023P0001 |
| 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 |
| Phone | +33299338650 |
| contact-intFA@enovis.com | |
| Phone | +33299338650 |
| contact-intFA@enovis.com | |
| Phone | +33299338650 |
| contact-intFA@enovis.com | |
| Phone | +33299338650 |
| contact-intFA@enovis.com | |
| Phone | +33299338650 |
| contact-intFA@enovis.com | |
| Phone | +33299338650 |
| contact-intFA@enovis.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700879517940 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700879517940]
Moist Heat or Steam Sterilization
[03700879517940]
Moist Heat or Steam Sterilization
[03700879517940]
Moist Heat or Steam Sterilization
[03700879517940]
Moist Heat or Steam Sterilization
[03700879517940]
Moist Heat or Steam Sterilization
[03700879517940]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-21 |
| Device Publish Date | 2025-11-13 |
| 03700879516233 | Bunion implant Ø4 lg30 |
| 03700879517957 | Lid |
| 03700879517940 | Tray |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PECA 98493443 not registered Live/Pending |
Harvest Partners, LP 2024-04-10 |
![]() PECA 98493443 not registered Live/Pending |
New Mountain Finance Advisors BDC, L.L.C. 2024-04-10 |
![]() PECA 79132922 4545743 Live/Registered |
CALZATURIFICIO CARMENS S.P.A. 2013-04-30 |
![]() PECA 79033768 3288442 Dead/Cancelled |
Max Frank Pressig GmbH 2006-08-24 |