Fibreplast® with Integrated Shim™ RT-A782KSD

GUDID 10841962117903

Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std Perf w/ Integrated Shim

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 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 ID10841962117903
NIH Device Record Key97f27f2d-9e7b-4e95-828a-fd21e695631d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibreplast® with Integrated Shim™
Version Model NumberRT-A782KSD
Catalog NumberRT-A782KSD
Company DUNS808875397
Company NameQfix
Device Count5
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
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
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter
Depth2.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962117897 [Primary]
GS110841962117903 [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 Date2021-12-28
Device Publish Date2021-12-20

On-Brand Devices [Fibreplast® with Integrated Shim™]

10841962117996Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm Std Perf w/ Integrated Shim
10841962117972Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm Std Perf w/ Integrated Shim
10841962117903Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std Perf w/ Integrated Shim
10841962117880Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std Perf w/ Integrated Shim

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.