Fibreplast® Assure™ Open View RT-1778KFORF5

GUDID 10841962110140

Assure Open View Fibreplast 5 Point Mask

Qfix

Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material
Primary Device ID10841962110140
NIH Device Record Key3fddb52d-154f-4928-ab4b-f47a6821283e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibreplast® Assure™ Open View
Version Model NumberRT-1778KFORF5
Catalog NumberRT-1778KFORF5
Company DUNS808875397
Company NameQfix
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
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(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 Dimensions

Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962106068 [Unit of Use]
GS110841962110140 [Primary]

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-04
Device Publish Date2017-01-05

On-Brand Devices [Fibreplast® Assure™ Open View]

10841962111888Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks
10841962111864Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks
10841962114377Assure Open View Fibreplast 5 Point Mask
10841962114353Assure Open View Fibreplast 5 Point Mask
10841962110584Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks
10841962110577Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks
10841962110553Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks
10841962110546Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks
10841962110140Assure Open View Fibreplast 5 Point Mask
10841962110133Assure Open View Fibreplast 3-Point Mask
10841962110249Assure Open View Fibreplast 5 Point Mask
10841962110232Assure Open View Fibreplast 3 Point Mask

Trademark Results [Fibreplast]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIBREPLAST
FIBREPLAST
85862461 4414349 Live/Registered
Qfix Systems LLC
2013-02-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.