VIPER PRIME 301019010
GUDID 10705034561684
NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER
Medos International Sàrl
Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable 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 |
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| Phone | +1(800)255-2500 |
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| 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 |
Trademark Results [VIPER PRIME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIPER PRIME 86819099 5464979 Live/Registered |
DePuy Synthes, Inc. 2015-11-13 |
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