PATIENT REFERENCE (V3) ROSAS00183

GUDID 03760244033567

"PATIENT REFERENCE Instrument ROSA ONE 3.1 (spine application) Passive reference frame mounted on the percutaneous pin implanted in the iliac crest or mounted on the spinous clamp"

MEDTECH

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244033567
• NIH Device Record Key: 9a55e7d4-49d8-456d-91e0-2b9f55007459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATIENT REFERENCE (V3)
• Version Model Number: 174036-01
• Catalog Number: ROSAS00183
• Company DUNS: 264502977
• Company Name: MEDTECH
• 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: true
• 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	03760244033567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182848

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

[03760244033567]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-06-08

On-Brand Devices [PATIENT REFERENCE (V3)]

• 03760244032225: "PATIENT REFERENCE Instrument ROSA ONE 3.1 (spine application) Passive reference frame mounted o
• 03760244033567: "PATIENT REFERENCE Instrument ROSA ONE 3.1 (spine application) Passive reference frame mounted o