Erisma®-LP Navigated 98709001
GUDID 03700780639212
TIGHTENING KEY FOR NAV. TAP FOR FIXED GUIDEWIRE
CLARIANCE
Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 03700780639212 |
| NIH Device Record Key | 9ddb3b96-87a1-48a2-984e-60f286218fc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Erisma®-LP Navigated |
| Version Model Number | 98709001 |
| Catalog Number | 98709001 |
| 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 | 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 | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us | |
| Phone | 7738687041 |
| s.chambat@clariance-spine.us |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780639212 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202956
FDA Product Code
| OLO | Orthopedic Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
[03700780639212]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
On-Brand Devices [Erisma®-LP Navigated]
| 03700780644148 | NAVIGATED TAP FOR FIXED GUIDEWIRE (Ø5,50 MM) |
| 03700780644063 | DEPTH GAUGE FOR NAV. TAP FOR FIXED GUIDEWIRE |
| 03700780643851 | NAVIGATED TAP FOR FIXED GUIDEWIRE (Ø4,50 MM) |
| 03700780639212 | TIGHTENING KEY FOR NAV. TAP FOR FIXED GUIDEWIRE |
Trademark Results [Erisma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERISMA 79093033 4152212 Live/Registered |
CLARIANCE S.A.S 2011-01-04 |
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