Ru-106 Eye Applicator without ears, type CCB 19 MB RU6.A06-E

GUDID 04049223100841

Eckert & Ziegler BEBIG GmbH

Manual brachytherapy source, temporary placement
Primary Device ID04049223100841
NIH Device Record Key2a15afa0-782c-4b27-92ce-098bf5fc2732
Commercial Distribution Discontinuation2016-09-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRu-106 Eye Applicator without ears, type CCB 19 MB
Version Model NumberRU6.A06-E
Catalog NumberRU6.A06-E
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
GS104049223100841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04049223100841]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

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