Personalized PseudoPatient™ PV PFL-02PV

GUDID 00860001523218

Personalized PseudoPatient™ PV FL

RTSAFE, INC.

Custom-made organ/bone anatomy model

• Primary Device ID: 00860001523218
• NIH Device Record Key: 8fe98bd2-848c-4f95-ac21-152a9e87efbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Personalized PseudoPatient™ PV
• Version Model Number: PFL-02PV
• Catalog Number: PFL-02PV
• Company DUNS: 080928779
• Company Name: RTSAFE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-542-5822
• Email: tpapanikolaou@rt-safe.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001523218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180697

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-05-31

On-Brand Devices [Personalized PseudoPatient™ PV]

• 00860001523218: Personalized PseudoPatient™ PV FL
• 00860001523201: Personalized PseudoPatient™ PV IC