| Primary Device ID | 03700879516455 | 
| NIH Device Record Key | 04e3a8a5-19a3-4cf1-aa12-d1a597a6f1f8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pecaplasty® | 
| Version Model Number | SKW06002 | 
| Catalog Number | SKW06002 | 
| 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 | 03700879516455 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-12-02 | 
| Device Publish Date | 2022-11-24 | 
| 03700879516455 | Sterile traction wire Ø2.5 lg128 | 
| 03700879516448 | Traction wire Ø2.5 lg128 | 
| 03700879517612 | Targeting guide 2.0 wires first | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() PECAPLASTY  97029206  not registered Live/Pending  | 
        NOVASTEP  2021-09-15  |