Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile) LAA1400-GYN

GUDID 04049223132613

Eckert & Ziegler BEBIG GmbH

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID04049223132613
NIH Device Record Keyd9e73106-bbc3-4a00-99cd-c0d29f485e0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Applicator incl. plug, D=3mm, L=1400mm (non sterile)
Version Model NumberLAA1400-GYN#02
Catalog NumberLAA1400-GYN
Company DUNS331080432
Company NameEckert & Ziegler BEBIG GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com
Phone+49309410840
Emailinfo@bebig.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049223132613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

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04049223100858 - Ru-106 Eye Applicator with slot, type CCB 19 MBq2020-07-01
04049223100872 - Ru-106 Eye Applicator with slot, type CGD 24 MBq2020-07-01

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