WP1D

GUDID EIBAM9006100V0010

WP1D manual water phantom

IBA Dosimetry GmbH

Accelerator system quality assurance device
Primary Device IDEIBAM9006100V0010
NIH Device Record Key52dd244b-b41e-45e8-a543-855f2781de53
Commercial Distribution StatusIn Commercial Distribution
Brand NameWP1D
Version Model NumberM9006100#001
Company DUNS332599307
Company NameIBA Dosimetry GmbH
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

Phone+861080809107
EmailServiceAPAC@iba-group.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEIBAM9006100V0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-09

On-Brand Devices [WP1D]

EIBAM90061200WP1D motorized water phantom including Smart Control Unit (SCU)
EIBAM90061100WP1D motorized water phantom with interface to CU500E
EIBAM9006100V0010WP1D manual water phantom

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