| Primary Device ID | 00860005968824 |
| NIH Device Record Key | 7b737e34-1a3f-4e0a-b9eb-213d21a3456b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RELJA Innovations Nitinol Staple Kit 15mmx12mm |
| Version Model Number | RI-NS-15 |
| Company DUNS | 113596350 |
| Company Name | Relja Innovations LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005968824 [Primary] |
| JDR | Staple, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-29 |
| Device Publish Date | 2025-09-19 |
| 00860005968824 - RELJA Innovations Nitinol Staple Kit 15mmx12mm | 2025-09-29RELJA Innovations Nitinol Staple Kit 15mmx12mm |
| 00860005968824 - RELJA Innovations Nitinol Staple Kit 15mmx12mm | 2025-09-29 RELJA Innovations Nitinol Staple Kit 15mmx12mm |
| 00860005968831 - RELJA Innovations Nitinol Staple Kit 18x18 | 2025-09-29 RELJA Innovations Nitinol Staple Kit 18x18 |
| 00860005968800 - MIS Precision Chevron Bunion System | 2024-02-19 The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subseq |
| 00860005968817 - RELJA Reduction Clamp (Left and Right) | 2024-01-11 The Relja Innovations Reduction Clamp is a manual surgical instrument intended to position and compress the metatarsal joints du |