Horizon Subtalar Gen 2 Sizing Probe 9mm

GUDID M20922658

BIOPRO, INC.

Orthopaedic bone screw starter/notcher

• Primary Device ID: M20922658
• NIH Device Record Key: 652a508f-ebae-4e1b-800b-8ebfc366d4d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Horizon Subtalar Gen 2 Sizing Probe 9mm
• Version Model Number: 22658
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	M20922658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041936

FDA Product Code

• HXB: Probe

Sterilization

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

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

[M20922658]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-01
• Device Publish Date: 2020-09-23

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