S3D OTI Camera

GUDID 07290019120261

PATHKEEPER SURGICAL LTD

Optical surgical navigation device tracking system

• Primary Device ID: 07290019120261
• NIH Device Record Key: 4a291bb5-45e2-4528-a5f5-2ea723ec0d0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S3D OTI Camera
• Version Model Number: EMA0001
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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	07290019120117 [Previous]
GS1	07290019120261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222355

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

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 [S3D OTI Camera]

• 07290019120117: EMA0001-01
• 07290019120261: EMA0001