ExoToe

GUDID B065EX055

ExoToe Staple 5.5

EXOTOE, LLC

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: B065EX055
• NIH Device Record Key: a014d899-6fc4-4533-80c3-df61750b7fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExoToe
• Version Model Number: EX055
• Company DUNS: 081016089
• Company Name: EXOTOE, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B065EX055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172205

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2020-06-29
• Device Publish Date: 2020-06-19

On-Brand Devices [ExoToe]

• B065EX075: ExoToe Staple 7.5
• B065EX070: ExoToe Staple 7.0
• B065EX065: ExoToe Staple 6.5
• B065EX060: ExoToe Staple 6.0
• B065EX055: ExoToe Staple 5.5
• B605EX075: ExoToe Staple 7.5
• B605EX070: ExoToe Staple 7.0
• B605EX065: ExoToe Staple 6.5
• B605EX060: ExoToe Staple 6.0
• B605EX055: ExoToe Staple 5.5
• B605SZR001: ExoToe Sizing Template 5.5mm, 6.5mm, 7.5mm
• B605FCP001: ExoToe Crimping Forceps