VIPER PRIME 186745360

GUDID 10705034508948

VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 4.5 x 60mm

Medos International Sàrl

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 10705034508948
• NIH Device Record Key: 9b7c2f8f-4ff3-4b48-929f-6e00c9b810d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIPER PRIME
• Version Model Number: 186745360
• Catalog Number: 186745360
• 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: 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
• 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	10705034508948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162912

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

[10705034508948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2017-05-01

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