PKS Accessories Setup DRF

GUDID 17290019120015

PATHKEEPER SURGICAL LTD

Optical surgical navigation device tracking system

• Primary Device ID: 17290019120015
• NIH Device Record Key: 56f5aa03-ac8c-4cfd-8167-4896a48cb2f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS Accessories Setup DRF
• Version Model Number: MAS0001-01
• 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	07290019120018 [Primary]
GS1	17290019120015 [Package]; Contains: 07290019120018; 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

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

Moist Heat or Steam Sterilization

[17290019120015]

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 Accessories Setup DRF]

• 17290019120015: MAS0001-01
• 17290019120183: MAS0001