U-Arm System Basic

GUDID 00817100020025

Universal U-arm system - Motorized.

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

Stationary basic diagnostic x-ray system, digital
Primary Device ID00817100020025
NIH Device Record Key11e50237-1d60-4c30-9b10-9c556955feb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-Arm System Basic
Version Model NumberXR3001
Company DUNS080269345
Company NameKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com
Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com
Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817100020025 [Primary]

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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