Access Wrist Support RT-4546AW-01

GUDID 00841962119511

Access Wrist Support

Qfix

Radiological breast positioner, non-wearable
Primary Device ID00841962119511
NIH Device Record Key720cca50-5a90-4b43-8501-d609a10b8aac
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Wrist Support
Version Model NumberRT-4546AW-01
Catalog NumberRT-4546AW-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
GS100841962119511 [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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10841962119464 - Symphony Locating Bar, PH Style2025-12-03 Symphony Locating Bar, PH Style
00841962119856 - IntegraBite2025-11-21 IntegraBite Plates
00841962120340 - Edge Guide System2025-09-19 Lithotomy Edge Guide System
00841962119467 - Alpine Stirrups2025-07-17 Stirrup, Left

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