CCU Steuerelektronik PT

GUDID EIBAE14000300

IBA Dosimetry GmbH

Accelerator system quality assurance device
Primary Device IDEIBAE14000300
NIH Device Record Keyd167cda8-eb2d-4519-80e7-31cdd65b8162
Commercial Distribution StatusIn Commercial Distribution
Brand NameCCU Steuerelektronik PT
Version Model NumberE1400030
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com
Phone+1 901 386-2242
EmailUSService@iba-group.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEIBAE14000300 [Primary]

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-20
Device Publish Date2023-04-12

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EIBAHA050100 - Water Reservoir2023-08-11 Waterreservoir - bidirectional pump, 115V
EIBAE30702001 - myQA SRS Detector Cyberknife edition2023-08-02 myQA SRS Cyberknife edition
EIBAE20702000 - DOSE-X2023-04-21 DOSE-X Dosimeter TNC
EIBAE20703000 - DOSE-X2023-04-21 DOSE-X Dosimeter BNC

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