VIPER PRIME 301019010
GUDID 10705034561684
NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER
Medos International Sàrl
Surgical screwdriver, reusable| Primary Device ID | 10705034561684 |
| NIH Device Record Key | 1edd2651-67fa-4007-bad1-419e2cdaad8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VIPER PRIME |
| Version Model Number | 3010-19-010 |
| Catalog Number | 301019010 |
| Company DUNS | 482661753 |
| Company Name | Medos International Sàrl |
| 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 | false |
| 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(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034561684 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200791
FDA Product Code
| OLO | Orthopedic stereotaxic instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
[10705034561684]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-29 |
| Device Publish Date | 2020-10-21 |
On-Brand Devices [VIPER PRIME]
| 10705034507699 | VIPER PRIME ROD HOLDER PUSHROD |
| 10705034507682 | VIPER PRIME ROD HOLDER SHAFT |
| 10705034507675 | VIPER PRIME ROD HOLDER STEM |
| 10705034507668 | VIPER PRIME ROD GAUGE |
| 10705034529806 | VIPER PRIME Auxiliary Tray |
| 10705034529783 | VIPER PRIME FENESTRATED HALF TRAY |
| 10705034518671 | VIPER PRIME CFX FEN X-TAB TRAY 2 |
| 10705034518664 | VIPER PRIME CFX X-TAB TRAY 2 |
| 10705034518657 | VIPER PRIME X-TAB IMPLANT TRAY 2 |
| 10705034507538 | VIPER PRIME SCREW CADDY |
| 10705034507521 | VIPER PRIME IMPLANT TRAY |
| 10705034507514 | VIPER PRIME CFXFEN X-TAB TRAY |
| 10705034507507 | VIPER PRIME CFX X-TAB TRAY |
| 10705034507491 | VIPER PRIME X-TAB IMPL TRAY |
| 10705034507484 | VIPER PRIME IMPL CASE |
| 10705034507477 | VIPER PRIME INSTRUMENT TRAY 2 |
| 10705034507460 | VIPER PRIME INSTRUMENT TRAY 1 |
| 10705034507453 | VIPER PRIME INSTRUMENT CASE |
| 10705034507446 | VIPER PRIME NAVIGATION TRAY |
| 10705034561684 | NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER |
| 10705034548654 | VIPER PRIME Locking Post Driver |
| 10705034548647 | VIPER PRIME Locking Post |
| 10705034507774 | VIPER PRIME V3D SLEEVE |
| 10705034507828 | VIPER PRIME NAVIGATION STYLET |
| 10705034507811 | VIPER PRIME STYLET |
| 10705034530284 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 60mm |
| 10705034530277 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 55mm |
| 10705034530260 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 50mm |
| 10705034530253 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 45mm |
| 10705034530246 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 40mm |
| 10705034530239 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 35mm |
| 10705034530222 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 30mm |
| 10705034530215 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 60mm |
| 10705034530208 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 55mm |
| 10705034530192 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 50mm |
| 10705034530185 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 45mm |
| 10705034530178 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 40mm |
| 10705034530161 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 35mm |
| 10705034530154 | VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 30mm |
| 10705034530123 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 60mm |
| 10705034530116 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 55mm |
| 10705034530109 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 50mm |
| 10705034530093 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 45mm |
| 10705034530086 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 40mm |
| 10705034530079 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 35mm |
| 10705034530062 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 30mm |
| 10705034529981 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 60mm |
| 10705034529974 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 55mm |
| 10705034529967 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 50mm |
| 10705034529950 | VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 45mm |
Trademark Results [VIPER PRIME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIPER PRIME 86819099 5464979 Live/Registered |
DePuy Synthes, Inc. 2015-11-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.