VIPER PRIME 186750435

GUDID 10705034509174

VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 35mm

Medos International Sàrl

Spinal bone screw, non-bioabsorbable
Primary Device ID10705034509174
NIH Device Record Key4ed6fb83-a393-467a-9113-789e4c9de722
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIPER PRIME
Version Model Number186750435
Catalog Number186750435
Company DUNS482661753
Company NameMedos International Sàrl
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034509174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


[10705034509174]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-23
Device Publish Date2017-05-19

On-Brand Devices [VIPER PRIME]

10705034507699VIPER PRIME ROD HOLDER PUSHROD
10705034507682VIPER PRIME ROD HOLDER SHAFT
10705034507675VIPER PRIME ROD HOLDER STEM
10705034507668VIPER PRIME ROD GAUGE
10705034529806VIPER PRIME Auxiliary Tray
10705034529783VIPER PRIME FENESTRATED HALF TRAY
10705034518671VIPER PRIME CFX FEN X-TAB TRAY 2
10705034518664VIPER PRIME CFX X-TAB TRAY 2
10705034518657VIPER PRIME X-TAB IMPLANT TRAY 2
10705034507538VIPER PRIME SCREW CADDY
10705034507521VIPER PRIME IMPLANT TRAY
10705034507514VIPER PRIME CFXFEN X-TAB TRAY
10705034507507VIPER PRIME CFX X-TAB TRAY
10705034507491VIPER PRIME X-TAB IMPL TRAY
10705034507484VIPER PRIME IMPL CASE
10705034507477VIPER PRIME INSTRUMENT TRAY 2
10705034507460VIPER PRIME INSTRUMENT TRAY 1
10705034507453VIPER PRIME INSTRUMENT CASE
10705034507446VIPER PRIME NAVIGATION TRAY
10705034561684NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER
10705034548654VIPER PRIME Locking Post Driver
10705034548647VIPER PRIME Locking Post
10705034507774VIPER PRIME V3D SLEEVE
10705034507828VIPER PRIME NAVIGATION STYLET
10705034507811VIPER PRIME STYLET
10705034530284VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 60mm
10705034530277VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 55mm
10705034530260VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 50mm
10705034530253VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 45mm
10705034530246VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 40mm
10705034530239VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 35mm
10705034530222VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 x 30mm
10705034530215VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 60mm
10705034530208VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 55mm
10705034530192VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 50mm
10705034530185VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 45mm
10705034530178VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 40mm
10705034530161VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 35mm
10705034530154VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 x 30mm
10705034530123VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 60mm
10705034530116VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 55mm
10705034530109VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 50mm
10705034530093VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 45mm
10705034530086VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 40mm
10705034530079VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 35mm
10705034530062VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 x 30mm
10705034529981VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 60mm
10705034529974VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 55mm
10705034529967VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 50mm
10705034529950VIPER 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
VIPER PRIME
86819099 5464979 Live/Registered
DePuy Synthes, Inc.
2015-11-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.