VIPER PRIME 286750210S

GUDID 10705034507828

VIPER PRIME NAVIGATION STYLET

Medos International Sàrl

Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire

• Primary Device ID: 10705034507828
• NIH Device Record Key: 51735fab-a687-4e25-8616-ab9830c966ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIPER PRIME
• Version Model Number: 286750210S
• Catalog Number: 286750210S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034507828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170937

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-04-11
• Device Publish Date: 2017-09-22

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