Idys®-ALIF ZP 3DTi 45715000
GUDID 03700780630783
CAGE HOLDER
CLARIANCE
Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 03700780630783 |
| NIH Device Record Key | 420ff454-a613-4751-a2a6-86b23d1c7c35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Idys®-ALIF ZP 3DTi |
| Version Model Number | 45715000 |
| Catalog Number | 45715000 |
| Company DUNS | 296568400 |
| Company Name | CLARIANCE |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us | |
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us | |
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us | |
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us | |
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us | |
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us | |
| Phone | +1 773 868 7041 |
| s.chambat@clariance-spine.us |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780630783 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192168
FDA Product Code
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700780630783]
Moist Heat or Steam Sterilization
[03700780630783]
Moist Heat or Steam Sterilization
[03700780630783]
Moist Heat or Steam Sterilization
[03700780630783]
Moist Heat or Steam Sterilization
[03700780630783]
Moist Heat or Steam Sterilization
[03700780630783]
Moist Heat or Steam Sterilization
[03700780630783]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-31 |
| Device Publish Date | 2021-08-23 |
On-Brand Devices [Idys®-ALIF ZP 3DTi]
Trademark Results [Idys]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDYS 79237665 5682795 Live/Registered |
CLARIANCE 2018-04-11 |
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