3D X-Ray Pattern Phantom ROSAS00299

GUDID 03760244032263

"3D X-RAY PATTERN PHANTOM instrument Rosa one 3.1 (spine application) Mock-up of the 3D X-ray pattern to adjust intraoperative imaging system"

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244032263
• NIH Device Record Key: 704b9136-36db-4e54-a087-c4b1a7ed247f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D X-Ray Pattern Phantom
• Version Model Number: 224173-00
• Catalog Number: ROSAS00299
• 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	03760244032263 [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

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

[03760244032263]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-06-02

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