Advanced Universal U-Arm Stand 3000

GUDID 00817100020049

Advanced Universal U-arm Stand 3000 - 8' 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 ID00817100020049
NIH Device Record Key520983e9-2650-47df-9ca2-fa26342b60e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Universal U-Arm Stand 3000
Version Model NumberXR3002
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 HumidityBetween 10 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100817100020049 [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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