TOEGRIP® Retrograde TGRXS00

GUDID 03701091006113

Interphalangeal device

ADSM

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