3D X-RAY PATTERN PHANTOM ROSAS00156

GUDID 03760244030627

3D X-RAY PATTERN PHANTOM instrument Rosa one (spine application) Mock-up of the 3D X-ray pattern to adjust intraoperative imaging system

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 Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244030627
• NIH Device Record Key: 808ee85c-c8ae-40ba-8a46-c4975edcd229
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D X-RAY PATTERN PHANTOM
• Version Model Number: ROSA3-129B
• Catalog Number: ROSAS00156
• 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	03760244030627 [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

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

[03760244030627]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-20
• Device Publish Date: 2019-11-18

On-Brand Devices [3D X-RAY PATTERN PHANTOM]

• 03760244030627: 3D X-RAY PATTERN PHANTOM instrument Rosa one (spine application) Mock-up of the 3D X-ray pattern
• 03760244032263: "3D X-RAY PATTERN PHANTOM instrument Rosa one 3.1 (spine application) Mock-up of the 3D X-ray pa