TruGuard™ HNRT-3501

GUDID 10714646000412

TruGuard, Standard

Bionix, LLC

Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece Radiological head/neck positioning mouthpiece
Primary Device ID10714646000412
NIH Device Record Key5ce3aa61-11f0-45e8-906a-a9fb2fbc60c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruGuard™
Version Model NumberHNRT-3501
Catalog NumberHNRT-3501
Company DUNS117844489
Company NameBionix, LLC
Device Count25
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000415 [Primary]
GS110714646000412 [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 Date2022-01-17
Device Publish Date2022-01-08

Devices Manufactured by Bionix, LLC

00714646001252 - Lighted Articulating - Sample2024-06-24 Lighted Articulating Curette - Sample
10714646001198 - SecureFoam2024-06-10 SecureFoam - Small
10714646001204 - SecureFoam2024-06-10 SecureFoam - Medium
10714646001211 - SecureFoam2024-06-10 SecureFoam - Large
10714646001228 - SecureFoam2024-06-10 SecureFoam - SAMPLE Small
10714646001235 - SecureFoam2024-06-10 SecureFoam - SAMPLE Medium
10714646001242 - SecureFoam2024-06-10 SecureFoam - SAMPLE Large Box
00714646000101 - T-Form SecureVac Box Adaptor2024-05-20 T-Form SecureVac Box Adaptor

Trademark Results [TruGuard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUGUARD
TRUGUARD
98021583 not registered Live/Pending
Zomedica Inc.
2023-05-31
TRUGUARD
TRUGUARD
97829155 not registered Live/Pending
CAN Technologies, Inc.
2023-03-08
TRUGUARD
TRUGUARD
88917649 not registered Live/Pending
CAN Technologies, Inc.
2020-05-15
TRUGUARD
TRUGUARD
88412688 not registered Live/Pending
True Value Company, L.L.C.
2019-05-02
TRUGUARD
TRUGUARD
88385766 not registered Live/Pending
True Value Company, L.L.C.
2019-04-15
TRUGUARD
TRUGUARD
88140983 not registered Live/Pending
ZODIAC POOL SYSTEMS LLC
2018-10-03
TRUGUARD
TRUGUARD
88053421 not registered Live/Pending
True Value Company, L.L.C.
2018-07-26
TRUGUARD
TRUGUARD
87977499 5526411 Live/Registered
TRUE VALUE COMPANY, L.L.C.
2016-08-31
TRUGUARD
TRUGUARD
87861131 not registered Dead/Abandoned
TRUE VALUE COMPANY, L.L.C.
2018-04-03
TRUGUARD
TRUGUARD
87523524 not registered Dead/Abandoned
TRUE VALUE COMPANY, L.L.C.
2017-07-11
TRUGUARD
TRUGUARD
87453455 5656651 Live/Registered
TRUE VALUE COMPANY, L.L.C.
2017-05-17
TRUGUARD
TRUGUARD
87418572 5607889 Live/Registered
TRUE VALUE COMPANY, L.L.C.
2017-04-20
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