RTM 78 H

GUDID 08059307490474

Rotating anode X-ray tube for radiography systems

I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA

X-ray tube housing assembly, diagnostic

• Primary Device ID: 08059307490474
• NIH Device Record Key: d1194f6d-9419-42c0-b21b-63388a1efd08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTM 78 H
• Version Model Number: 1.0/2.0
• Company DUNS: 430263475
• Company Name: I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	08059307490474 [Primary]

FDA Product Code

• ITY: Assembly, Tube Housing, X-Ray, Diagnostic

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: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [RTM 78 H]

• 08059307490474: Rotating anode X-ray tube for radiography systems
• 08059307490467: Rotating anode X-ray tube for radiography systems
• 08059307490450: Rotating anode X-ray tube for radiography systems