| Primary Device ID | 03700780636457 |
| NIH Device Record Key | a1e30a6a-5781-4856-8bfd-fe4c8b45c375 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDYS-C® ZP 3DTi |
| Version Model Number | 44706001 |
| Catalog Number | 44706001 |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| 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 | |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780636457 [Primary] |
| OVE | Intervertebral fusion device with integrated fixation, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
[03700780636457]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-30 |
| Device Publish Date | 2021-11-22 |
| 03700780636525 | IDYS-C ZP 3DTI ANGLED DRILL |
| 03700780636518 | IDYS-C ZP 3DTI ANGLED SCREWDRIVER |
| 03700780636501 | RESCUE SCREWDRIVER |
| 03700780636495 | FLEXIBLE DRILL |
| 03700780636488 | Flexible Screwdriver |
| 03700780636471 | ANGULATED PUNCH |
| 03700780636464 | STRAIGHT PUNCH |
| 03700780636457 | SINGLE BARREL DRILL GUIDE |
| 03700780636440 | DRILL |
| 03700780636433 | GRAFT COMPACTOR |
| 03700780636426 | FILLING BLOCK |
| 03700780636419 | AO CYLINDRICAL HANDLE |
| 03700780636402 | LOCKING NUT |
| 03700780636396 | DISTRACTION PIN |
| 03700780636389 | DISTRACTION PIN |
| 03700780636372 | DISTRACTION PIN |
| 03700780636365 | DISTRACTOR |
| 03700780636358 | WEDGE TRIAL |
| 03700780636341 | WEDGE TRIAL |
| 03700780636334 | WEDGE TRIAL |
| 03700780636327 | WEDGE TRIAL |
| 03700780636310 | WEDGE TRIAL |
| 03700780636303 | WEDGE TRIAL |
| 03700780636297 | WEDGE TRIAL |
| 03700780636280 | WEDGE TRIAL |
| 03700780636273 | WEDGE TRIAL |
| 03700780636266 | WEDGE TRIAL |
| 03700780636259 | WEDGE TRIAL |
| 03700780636242 | WEDGE TRIAL |
| 03700780636235 | WEDGE TRIAL |
| 03700780636228 | WEDGE TRIAL |
| 03700780636211 | WEDGE TRIAL |
| 03700780636204 | ANATOMIC TRIAL |
| 03700780636198 | ANATOMIC TRIAL |
| 03700780636181 | ANTOMIC TRIAL |
| 03700780636174 | ANATOMIC TRIAL |
| 03700780636167 | ANATOMIC TRIAL |
| 03700780636150 | ANATOMIC TRAIL |
| 03700780636143 | ANATOMIC TRIAL |
| 03700780636136 | ANATOMIC TRIAL |
| 03700780636129 | ANATOMIC TRIAL |
| 03700780636112 | ANATOMIC TRIAL |
| 03700780636105 | ANATOMIC TRIAL |
| 03700780636099 | ANATOMIC TRIAL |
| 03700780636082 | ANATOMIC TRIAL |
| 03700780636075 | ANATOMIC TRIAL |
| 03700780636068 | ANATOMIC TRIAL |
| 03700780635979 | WEDGE CERVICAL CAGE |
| 03700780635603 | SCREWDRIVER T15 |
| 03700780635597 | CAGE HOLDER |