SCARLET® AC-T Secured Anterior Cervical Cage SCA-RE 35 18-S
GUDID 07640185341807
Self-drilling cervical screw
SpineArt SA
Spinal bone screw, non-bioabsorbable| Primary Device ID | 07640185341807 |
| NIH Device Record Key | dc5ba2e8-8684-4e2d-9b1a-7c5d7e21955a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCARLET® AC-T Secured Anterior Cervical Cage |
| Version Model Number | SCA-RE 35 18-S |
| Catalog Number | SCA-RE 35 18-S |
| 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 | 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 Dimensions
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640185341807 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190322
FDA Product Code
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2019-03-08 |
On-Brand Devices [SCARLET® AC-T Secured Anterior Cervical Cage]
| 07640151088668 | Secured Lordotic Anterior Cervical Cage / Large |
| 07640151088651 | Secured Lordotic Anterior Cervical Cage / Large |
| 07640151088644 | Secured Lordotic Anterior Cervical Cage / Large |
| 07640151088637 | Secured Lordotic Anterior Cervical Cage / Large |
| 07640151088620 | Secured Lordotic Anterior Cervical Cage / Large |
| 07640151088613 | Secured Lordotic Anterior Cervical Cage / Large |
| 07640151088606 | Secured Lordotic Anterior Cervical Cage / Small |
| 07640151088590 | Secured Lordotic Anterior Cervical Cage / Small |
| 07640151088583 | Secured Lordotic Anterior Cervical Cage / Small |
| 07640151088576 | Secured Lordotic Anterior Cervical Cage / Small |
| 07640151088569 | Secured Lordotic Anterior Cervical Cage / Small |
| 07640151088552 | Secured Lordotic Anterior Cervical Cage / Small |
| 07640151085193 | Cervical Revision Screw |
| 07640151085186 | Cervical Revision Screw |
| 07640151085179 | Cervical Revision Screw |
| 07640151085162 | Cervical Revision Screw |
| 07640151085155 | Cervical Screw |
| 07640151085148 | Cervical Screw |
| 07640151085131 | Cervical Screw |
| 07640151085124 | Cervical Screw |
| 07640151085117 | Secured Anterior Cervical Cage / Large |
| 07640151085100 | Secured Anterior Cervical Cage / Large |
| 07640151085094 | Secured Anterior Cervical Cage / Large |
| 07640151085087 | Secured Anterior Cervical Cage / Large |
| 07640151085070 | Secured Anterior Cervical Cage / Large |
| 07640151085063 | Secured Anterior Cervical Cage / Large |
| 07640151085056 | Secured Anterior Cervical Cage / Small |
| 07640151085049 | Secured Anterior Cervical Cage / Small |
| 07640151085032 | Secured Anterior Cervical Cage / Small |
| 07640151085025 | Secured Anterior Cervical Cage / Small |
| 07640151085018 | Secured Anterior Cervical Cage / Small |
| 07640151084998 | Secured Anterior Cervical Cage / Small |
| 07640185341807 | Self-drilling cervical screw |
| 07640185341791 | Self-drilling cervical screw |
| 07640185341784 | Self-drilling cervical screw |
| 07640185341777 | Self-drilling cervical screw |
| 07640185341760 | Self-drilling cervical screw |
| 07640185341753 | Self-drilling cervical screw |
| 07640185341746 | Self-drilling cervical screw |
| 07640185341739 | Self-drilling cervical screw |
| 07640185340893 | UNIVERSAL JOINT DRIVER |
Trademark Results [SCARLET]
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