Extend Frame system

GUDID 07340048305419

EXTEND MOUTH PIECE KIT

Elekta Instrument AB

Teletherapy radionuclide system, conventional
Primary Device ID07340048305419
NIH Device Record Keycb33281f-55db-4207-a9a6-9704f7b9b57c
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtend Frame system
Version Model Number1018667
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107340048305419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWBSystem, radiation therapy, radionuclide

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 Date2016-09-23

On-Brand Devices [Extend Frame system]

07340048307994EXTEND PATIENT PREPARATION KIT
07340048307970SALIVA STOP HOLDER (3PCS)
07340048306782HEIGHT COMPENSATION PLATE
07340048306775EXTEND CT OVERLAY ADAPTER KIT
07340048306768CT ADAPTER
07340048306744SALIVA STOP HOLDER KIT (3PCS)
07340048306737MIXER AND DISPENSER
07340048306720EXTEND SCREWDRIVER
07340048306713EXTEND PATIENT PREPERATION KIT
07340048306706CT ADAPTER
07340048305556EXTEND MOUTH PIECE S P2 (1PCS)
07340048305525EXTEND MOUTH PIECE XL P2 (1PCS)
07340048305495EXTEND MOUTH PIECE L (1PCS)
07340048305464EXTEND MOUTH PIECE M (1PCS)
07340048305433EXTEND MOUTH PIECE S (1PCS)
07340048305419EXTEND MOUTH PIECE KIT
07340048305396FILTER PCU KIT 10 PCS
07340048305372SALIVA STOP 1 PCS
07340048305341SALIVA STOP PCU (1 PCS)
07340048304597DIM ZHERMACK (1PCS)
07340048305051SALIVA STOP PAT. SPEC. (1 PCS)
07340048304603ADHESIVE
07340048304580DENTAL KIT ZHERMACK

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