Elekta Unity

GUDID 05060191071437

INDEXING BARS

ELEKTA LIMITED

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system
Primary Device ID05060191071437
NIH Device Record Key3b54ed34-5684-494d-92e2-482c9a4696e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameElekta Unity
Version Model Number1065120
Company DUNS525557559
Company NameELEKTA LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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+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
GS105060191071437 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-08
Device Publish Date2019-04-30

On-Brand Devices [Elekta Unity]

05060191071321Elekta Unity
05060191071437INDEXING BARS
05060191071420INDEXING BAR
05060191071598Elekta Unity
05060191071499Indexing Bars
05060191071482Indexing Bar
05060191071468CT OVERLAY

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