Access Arm Support RT-4546AA-01

GUDID 00841962119504

Access Arm Support

Qfix

Radiological breast positioner, non-wearable
Primary Device ID00841962119504
NIH Device Record Keyaf2baec8-f37b-47f9-9aaf-31bca86ba177
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Arm Support
Version Model NumberRT-4546AA-01
Catalog NumberRT-4546AA-01
Company DUNS808875397
Company NameQfix
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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

Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com
Phone800-842-8688
Emailregulatory@cqmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841962119504 [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 Date2025-07-17
Device Publish Date2025-07-09

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