TOEGRIP® CLASSIC

GUDID 00196449035748

ToeGrip Classic Extra-Large 10°

Tyber Medical, LLC

Phalangeal joint arthrodesis implant

• Primary Device ID: 00196449035748
• NIH Device Record Key: 9186eea8-15bb-49d4-b523-79727f343f8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOEGRIP® CLASSIC
• Version Model Number: TGXL10
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• 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: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com
• Phone: +1(866)761-0933
• Email: ra@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196449035748 [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: 2025-09-16
• Device Publish Date: 2025-09-08

On-Brand Devices [TOEGRIP® CLASSIC]

• 00196449035892: ToeGrip Classic Large 0°
• 00196449035885: ToeGrip Classic Large 10°
• 00196449035878: ToeGrip Classic Large 20°
• 00196449035861: ToeGrip Classic Medium 0°
• 00196449035854: ToeGrip Classic Medium 10°
• 00196449035847: ToeGrip Classic Medium 20°
• 00196449035830: ToeGrip Classic Small 0°
• 00196449035823: ToeGrip Classic Small 10°
• 00196449035816: ToeGrip Classic Small 20°
• 00196449035755: ToeGrip Classic Extra-Large 0°
• 00196449035748: ToeGrip Classic Extra-Large 10°
• 00196449035731: ToeGrip Classic Extra-Large 20°
• 00196449035724: ToeGrip Classic Extra-Small 0°
• 00196449035717: ToeGrip Classic Extra-Small 10°
• 00196449035700: ToeGrip Classic Extra-Small 20°