Ru-106 Eye Applicator, type CIB-2 15 MBq RU6.A15

GUDID 04049223100971

Eckert & Ziegler BEBIG GmbH

Manual brachytherapy source, temporary placement
Primary Device ID04049223100971
NIH Device Record Key1ccb80b0-697f-42bc-a5a5-3578c741fdb1
Commercial Distribution Discontinuation2020-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRu-106 Eye Applicator, type CIB-2 15 MBq
Version Model NumberRU6.A15
Catalog NumberRU6.A15
Company DUNS331080432
Company NameEckert & Ziegler BEBIG GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4930941084130
Emailinfo@bebig.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Applicators must be stored in a dry state and with sufficient shielding in a locked safe. The Ru-106 eye applicator must not be stored in liquids or in the vicinity of media that promote corrosion.

Device Identifiers

Device Issuing AgencyDevice ID
GS104049223100971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04049223100971]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-01
Device Publish Date2015-09-24

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