PKS DRF 3-ID12.2

GUDID 17290019120077

PATHKEEPER SURGICAL LTD

Optical surgical navigation device tracking system

• Primary Device ID: 17290019120077
• NIH Device Record Key: b6a3fef6-ec7e-49d2-8603-f65594930c0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS DRF 3-ID12.2
• Version Model Number: MAS0007-01
• Company DUNS: 532374343
• Company Name: PATHKEEPER SURGICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	07290019120070 [Primary]
GS1	17290019120077 [Package]; Contains: 07290019120070; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222355

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

[17290019120077]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-23

On-Brand Devices [PKS DRF 3-ID12.2]

• 17290019120077: MAS0007-01
• 17290019120305: MAS0007