Eagle Radiation Therapy Pallet RT-4550SEA

GUDID 10841962111215

Eagle Radiation Therapy Pallet

Qfix

Indexed-immobilization patient positioning system
Primary Device ID10841962111215
NIH Device Record Key3ace21f7-2063-4137-9a51-0f7b1b893278
Commercial Distribution StatusIn Commercial Distribution
Brand NameEagle Radiation Therapy Pallet
Version Model NumberRT-4550SEA
Catalog NumberRT-4550SEA
Company DUNS808875397
Company NameQfix
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(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962111215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAICouch, radiation therapy, powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-04
Device Publish Date2021-07-27

Devices Manufactured by Qfix

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10841962107409 - Aquaplast PS™2023-12-11 Blush, 1/16" Small Silver splint, pkg. of 10
10841962107423 - Aquaplast PS™2023-12-11 Blush, 1/16" Large Silver splint, pkg. of 10
10841962107447 - Aquaplast PS™2023-12-11 Blush, 1/16" Tie Down Dressings, 6" x 9" sheet
10841962107461 - Aquaplast PS™2023-12-11 Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
10841962107485 - Aquaplast PS™2023-12-11 Blush, 1/16", Trapezoidal Nasal Splints
10841962107492 - Aquaplast PS™2023-12-11 Blush, 3/32", 3 x 3" Nasal Splint Blanks
10841962107515 - Aquaplast PS™2023-12-11 Blush, 3/32", 18" x 24" sheet

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