Erisma®-LP MIS 13435095
GUDID 03700780645121
MIS PRE-LORDOSED ROD
CLARIANCE
Bone-screw internal spinal fixation system rod| Primary Device ID | 03700780645121 |
| NIH Device Record Key | 5753ce93-a787-46f4-9706-2abe519e52e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Erisma®-LP MIS |
| Version Model Number | 13435095 |
| Catalog Number | 13435095 |
| 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 |
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 |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 95 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780645121 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162367
FDA Product Code
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
[03700780645121]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-10 |
| Device Publish Date | 2024-12-02 |
On-Brand Devices [Erisma®-LP MIS]
| 03700780645121 | MIS PRE-LORDOSED ROD |
| 03700780645114 | MIS PRE-LORDOSED ROD |
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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