TOEGRIP® Classic TGXL00

GUDID 03701091000289

Interphalangeal device

ADSM

Interphalangeal joint arthrodesis implant

• Primary Device ID: 03701091000289
• NIH Device Record Key: 7b59f6ca-d45e-4380-a9fb-e29fc6947277
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOEGRIP® Classic
• Version Model Number: TGXL00
• Catalog Number: TGXL00
• Company DUNS: 266749350
• Company Name: ADSM
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com

Device Dimensions

• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree
• Device Size Text, specify: 0
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701091000289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133477

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-24
• Device Publish Date: 2020-12-16

On-Brand Devices [TOEGRIP® Classic]

• 03701091000302: Interphalangeal device
• 03701091000296: Interphalangeal device
• 03701091000289: Interphalangeal device
• 03701091000272: Interphalangeal device
• 03701091000265: Interphalangeal device
• 03701091000258: Interphalangeal device
• 03701091000241: Interphalangeal device
• 03701091000234: Interphalangeal device
• 03701091000227: Interphalangeal device
• 03701091000210: Interphalangeal device
• 03701091000203: Interphalangeal device
• 03701091000197: Interphalangeal device
• 03701091000180: Interphalangeal device
• 03701091000173: Interphalangeal device
• 03701091000166: Interphalangeal device