GUDID 05060191070928

Applicator 20 x 6

ELEKTA LIMITED

Linear accelerator system
Primary Device ID05060191070928
NIH Device Record Key9d4df634-3de0-4efc-9d2b-b5347f586f3a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1525341
Company DUNS525557559
Company NameELEKTA LIMITED
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(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com
Phone+1(855)693-5358
Emailsystems.support.na@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060191070928 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ELEKTA LIMITED

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05060191071482 - Elekta Unity2021-12-08 Indexing Bar
05060191071499 - Elekta Unity2021-12-08 Indexing Bars
05060191071598 - Elekta Unity2021-12-08 Elekta Unity
05060191071345 - Integrity™2020-01-20 Integrity
05060191071420 - Elekta Unity2019-05-08 INDEXING BAR
05060191071437 - Elekta Unity2019-05-08 INDEXING BARS
05060191071321 - Elekta Unity2019-02-25 Elekta Unity

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