TOEGRIP® Retrograde TGRXS00

GUDID 03701091006113

Interphalangeal device

ADSM

Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant Interphalangeal joint arthrodesis implant

• Primary Device ID: 03701091006113
• NIH Device Record Key: f5d755a7-ba08-4365-ab13-9dedd920fe7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOEGRIP® Retrograde
• Version Model Number: TGRXS00
• Catalog Number: TGRXS00
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	03701091006113 [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: 2022-07-15
• Device Publish Date: 2022-07-07

Devices Manufactured by ADSM

• 03701091006250 - PURIST: 2023-05-02 OLH - US/EU - B
• 03701091006267 - PURIST: 2023-05-02 OLH - DENYER - B
• 03701091006274 - PURIST: 2023-05-02 OLH - DENYER PLUS - B
• 03701091006281 - PURIST: 2023-05-02 OLH - Boot M - B
• 03701091006298 - PURIST: 2023-05-02 OLH - Boot S - B
• 03701091006304 - PURIST: 2023-05-02 OLH #ED - B
• 03701091006311 - PURIST: 2023-05-02 OLH #BHA - B
• 03701091006328 - PURIST: 2023-05-02 OLH #ER - B