Elekta Medical Linear Accelerator

GUDID 05060191071512

Elekta Infinity™

Elekta Solutions AB

Linear accelerator system
Primary Device ID05060191071512
NIH Device Record Keyded73278-10ac-48d2-bce3-4e3eb00b4caf
Commercial Distribution StatusIn Commercial Distribution
Brand NameElekta Medical Linear Accelerator
Version Model Number1550358
Company DUNS353272181
Company NameElekta Solutions AB
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060191071512 [Primary]

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 Date2021-08-09
Device Publish Date2021-07-30

On-Brand Devices [Elekta Medical Linear Accelerator]

05060191071604Elekta Harmony Pro
05060191071581Elekta Harmony
05060191071574Versa HD™
05060191071550Elekta Synergy®
05060191071543Elekta Infinity™
05060191071529Versa HD™
05060191071512Elekta Infinity™
05060191071505Elekta Synergy®

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