Fibreplast® Variable Perf ™ Assure™ Open View RT-1776KYSDGXF

GUDID 10841962111642

Fibreplast Open View Splt Hd Only S-Frame Variable

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 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 ID10841962111642
NIH Device Record Keyc6c96b3e-2d60-4610-9769-a88900788a33
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibreplast® Variable Perf ™ Assure™ Open View
Version Model NumberRT-1776KYSDGXF
Catalog NumberRT-1776KYSDGXF
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 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
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
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
GS110841962111635 [Primary]
GS110841962111642 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-14

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

10841962111642Fibreplast Open View Splt Hd Only S-Frame Variable
10841962111628Fibreplast Open View Splt Hd Only S-Frame Variable

Trademark Results [Fibreplast]

Mark Image

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

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