| Primary Device ID | 07640332478639 |
| NIH Device Record Key | 23a23c49-c44e-4546-bf50-bd229ce9ef5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCARLET AC-Ti |
| Version Model Number | SCA-BX 80 01-N |
| Catalog Number | SCA-BX 80 01-N |
| Company DUNS | 483016148 |
| Company Name | SpineArt SA |
| 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 | 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 | 07640332478639 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
[07640332478639]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-28 |
| Device Publish Date | 2025-11-20 |
| 07640332478677 | HYPERLORDOTIC TRIAL RACK |
| 07640332478660 | LORDOTIC TRIAL RACK |
| 07640332478653 | ANATOMIC SMOOTH TRIAL RACK |
| 07640332478639 | INSTRUMENTATION CONTAINER |