U-Arm System

GUDID 00817100020032

Universal U-arm system - With Motorized Auto Positioning and Touchscreen control

KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00817100020032
• NIH Device Record Key: 7cd98c49-bc7a-42fd-bbf5-a49dfa5b09d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Arm System
• Version Model Number: XR3000
• Company DUNS: 080269345
• Company Name: KONICA MINOLTA MEDICAL IMAGING U.S.A., 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com
• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com
• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817100020032 [Primary]

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2018-03-29
• Device Publish Date: 2016-09-24

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