X-Trans™ HB-1 Armboard 8002041

GUDID 10841962109625

X-Trans Armboards: HB-1 Armboard

Qfix

Radiological arm/leg positioner
Primary Device ID10841962109625
NIH Device Record Keya25136c3-b0d7-449c-a685-73db678d6fe8
Commercial Distribution Discontinuation2017-03-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameX-Trans™ HB-1 Armboard
Version Model Number8002041
Catalog Number8002041
Company DUNS808875397
Company NameQfix
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

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
GS110841962109625 [Primary]

FDA Product Code

GDCTABLE, OPERATING-ROOM, ELECTRICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-11
Device Publish Date2016-12-22

Devices Manufactured by Qfix

00841962119467 - Alpine Stirrups2025-07-17 Stirrup, Left
00841962119474 - Alpine Stirrups2025-07-17 Stirrup, Right
00841962119481 - Symphony™2025-07-17 Alta AirShuttle Upgrade
00841962119498 - AirDrive Trolley™2025-07-17 AirDrive Trolley IV Pole
00841962119504 - Access Arm Support2025-07-17 Access Arm Support
00841962119511 - Access Wrist Support2025-07-17 Access Wrist Support
00841962119528 - AirShuttle Locating Bar2025-07-17 AirShuttle Locating Bar, Elekta Compatible
00841962119535 - AirShuttle Locating Bar2025-07-17 AirShuttle Locating Bar, Varian Compatible

Trademark Results [X-Trans]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-TRANS
X-TRANS
79263488 not registered Live/Pending
FUJIFILM Corporation
2019-05-22

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.