PKS Patient Reference DRF

GUDID 17290019120343

PATHKEEPER SURGICAL LTD

Optical surgical navigation device tracking system

• Primary Device ID: 17290019120343
• NIH Device Record Key: a1ab4fe9-ade5-44ec-8b30-f4285309ecf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS Patient Reference DRF
• Version Model Number: MAS0002
• 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	07290019120193 [Previous]
GS1	07290019120346 [Primary]
GS1	17290019120343 [Package]; Contains: 07290019120346; Package: pouch [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

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

[17290019120343]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [PKS Patient Reference DRF]

• 17290019120022: MAS0002-01
• 17290019120206: MAS0002
• 17290019120343: MAS0002