| Primary Device ID | 07640375236043 |
| NIH Device Record Key | eefd205a-6cf8-4f79-917f-1f6e5b4281fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cure OPEL-C |
| Version Model Number | 1100-400-02 |
| Catalog Number | 1100-400-02 |
| Company DUNS | 483016148 |
| Company Name | SpineArt SA |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | 07640375236043 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
[07640375236043]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-25 |
| Device Publish Date | 2025-11-17 |
| 07640375236074 | DOUBLE BARREL DRILL GUIDE, VARIABLE |
| 07640375236067 | DOUBLE BARREL DRILL GUIDE, FIXED |
| 07640375236050 | OPEL-C FORK, RESCUE |
| 07640375236043 | OPEL-C INSERTER |
| 07640375236012 | NON-STERILE CURE OPEL-C (S), 21MM, PLATE TEMPLATE |
| 07640375236005 | NON-STERILE CURE OPEL-C (S), 20MM, PLATE TEMPLATE |
| 07640375235992 | NON-STERILE CURE OPEL-C (S), 19MM, PLATE TEMPLATE |
| 07640375235985 | NON-STERILE CURE OPEL-C (S), 18MM, PLATE TEMPLATE |
| 07640375235978 | NON-STERILE CURE OPEL-C (S), 17MM, PLATE TEMPLATE |
| 07640375235961 | NON-STERILE CURE OPEL-C (S), 16MM, PLATE TEMPLATE |
| 07640375235930 | STERILE OPEL-C (S), 21MM, 1 LEVEL PLATE |
| 07640375235923 | STERILE OPEL-C (S), 20MM, 1 LEVEL PLATE |
| 07640375235916 | STERILE OPEL-C (S), 19MM, 1 LEVEL PLATE |
| 07640375235909 | STERILE OPEL-C (S), 18MM, 1 LEVEL PLATE |
| 07640375235893 | STERILE OPEL-C (S), 17MM, 1 LEVEL PLATE |
| 07640375235886 | STERILE OPEL-C (S), 16MM, 1 LEVEL PLATE |
| 07640375235947 | STERILE OPEL-C (S), 22MM, 1 LEVEL PLATE |
| 07640375236081 | CURE OPEL-C TRAY - BASE |