PKS DRF 3 - ID 12.2

GUDID 17290019120374

PATHKEEPER SURGICAL LTD

Optical surgical navigation device tracking system

• Primary Device ID: 17290019120374
• NIH Device Record Key: 4812e7d5-838a-4bf1-948b-b35742bd3c4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS DRF 3 - ID 12.2
• Version Model Number: MAS0007
• 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	07290019120292 [Previous]
GS1	07290019120377 [Primary]
GS1	17290019120374 [Package]; Contains: 07290019120377; 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

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

Moist Heat or Steam Sterilization

[17290019120374]

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

Devices Manufactured by PATHKEEPER SURGICAL LTD

• 07290019120261 - S3D OTI Camera: 2024-03-20
• 17290019120336 - PathKeeper Surgical Accessories Kit: 2024-03-20
• 17290019120343 - PKS Patient Reference DRF: 2024-03-20
• 17290019120350 - PKS DRF 2 - ID 5.9: 2024-03-20
• 17290019120367 - PKS DRF 4 - ID 7.9: 2024-03-20
• 17290019120374 - PKS DRF 3 - ID 12.2: 2024-03-20
• 17290019120374 - PKS DRF 3 - ID 12.2: 2024-03-20
• 17290019120183 - PKS Accessories Setup DRF: 2023-11-28
• 17290019120206 - PKS Patient Reference DRF: 2023-11-28