Encompass™ SRS Fibreplast® Anterior Mask RT-B889KYCF2A

GUDID 10841962118726

Encompass™ Fibreplast® Variable Perf Open View Anterior Only

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
Primary Device ID10841962118726
NIH Device Record Key8bc1adfb-76a0-44e5-af8d-eb7b7ed2326c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncompass™ SRS Fibreplast® Anterior Mask
Version Model Number10841962118726
Catalog NumberRT-B889KYCF2A
Company DUNS808875397
Company NameQfix
Device Count1
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

Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com
Phone610-268-0585
EmailCompliance@qfix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962118726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-29
Device Publish Date2021-12-21

Devices Manufactured by Qfix

10841962107386 - Aquaplast PS™2023-12-11 Blush, 1/16" - 3" x 3" Nasal Splint Blanks
10841962107409 - Aquaplast PS™2023-12-11 Blush, 1/16" Small Silver splint, pkg. of 10
10841962107423 - Aquaplast PS™2023-12-11 Blush, 1/16" Large Silver splint, pkg. of 10
10841962107447 - Aquaplast PS™2023-12-11 Blush, 1/16" Tie Down Dressings, 6" x 9" sheet
10841962107461 - Aquaplast PS™2023-12-11 Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
10841962107485 - Aquaplast PS™2023-12-11 Blush, 1/16", Trapezoidal Nasal Splints
10841962107492 - Aquaplast PS™2023-12-11 Blush, 3/32", 3 x 3" Nasal Splint Blanks
10841962107515 - Aquaplast PS™2023-12-11 Blush, 3/32", 18" x 24" sheet

Trademark Results [Encompass]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENCOMPASS
ENCOMPASS
98223659 not registered Live/Pending
PT Intermediate Holdings IV, LLC
2023-10-13
ENCOMPASS
ENCOMPASS
98052738 not registered Live/Pending
C. R. Bard, Inc.
2023-06-21
ENCOMPASS
ENCOMPASS
97826783 not registered Live/Pending
Beauflor USA, LLC
2023-03-07
ENCOMPASS
ENCOMPASS
97825234 not registered Live/Pending
QFIX SYSTEMS LLC
2023-03-06
ENCOMPASS
ENCOMPASS
97550970 not registered Live/Pending
Mirvie, Inc.
2022-08-16
ENCOMPASS
ENCOMPASS
97353368 not registered Live/Pending
Eyefinity, Inc.
2022-04-08
ENCOMPASS
ENCOMPASS
90975828 not registered Live/Pending
The Scoular Company
2021-02-23
ENCOMPASS
ENCOMPASS
90721158 not registered Live/Pending
Zest IP Holdings, LLC
2021-05-19
ENCOMPASS
ENCOMPASS
90542380 not registered Live/Pending
The Scoular Company
2021-02-23
ENCOMPASS
ENCOMPASS
90528107 not registered Live/Pending
Farmers Feed Mill, Inc.
2021-02-12
ENCOMPASS
ENCOMPASS
90491889 not registered Live/Pending
QFIX SYSTEMS LLC
2021-01-27
ENCOMPASS
ENCOMPASS
90124127 not registered Live/Pending
Toshiba America Business Solutions, Inc.
2020-08-19
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.