LDA-99 SC and emXX

GUDID EIBAE30420301

IBA Dosimetry GmbH

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device
Primary Device IDEIBAE30420301
NIH Device Record Key2bb803d9-3df9-4bc5-8689-aa24f1c6a376
Commercial Distribution StatusIn Commercial Distribution
Brand NameLDA-99 SC and emXX
Version Model NumberE3042030
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEIBAE30420300 [Primary]
HIBCCEIBAE30420301 [Package]
Contains: EIBAE30420300
Package: Carry Case [1 Units]
In Commercial Distribution

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-09

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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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