Erisma®-MIS 13057540
GUDID 03700780650552
LATERAL MIS UNIPLANAR SCREW
CLARIANCE
Spinal bone screw, non-bioabsorbable| Primary Device ID | 03700780650552 |
| NIH Device Record Key | 001562da-b53d-442c-b617-294e97576958 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Erisma®-MIS |
| Version Model Number | 13057540 |
| Catalog Number | 13057540 |
| 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
Device Dimensions
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780650552 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241863
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
[03700780650552]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-10 |
| Device Publish Date | 2024-09-02 |
On-Brand Devices [Erisma®-MIS]
| 03700780644100 | MIS PRE-LORDOSED ROD |
| 03700780644094 | MIS PRE-LORDOSED ROD |
| 03700780644087 | MIS PRE-LORDOSED ROD |
| 03700780650323 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650316 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650309 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650293 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651306 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651290 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651283 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651276 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651269 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651252 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651245 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651238 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651221 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651214 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651207 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651191 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651177 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651146 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651139 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651108 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651092 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651078 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651061 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651047 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651030 | LATERAL MIS UNIPLANAR SCREW |
| 03700780651016 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650996 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650989 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650972 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650958 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650934 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650927 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650910 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650903 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650897 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650828 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650811 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650804 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650798 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650781 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650774 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650767 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650750 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650743 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650736 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650729 | LATERAL MIS UNIPLANAR SCREW |
| 03700780650712 | LATERAL MIS UNIPLANAR SCREW |
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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