Tube Guard

GUDID B064HB11200101

XENCO MEDICAL LLC

Endoscopic bite block, basic, single-use
Primary Device IDB064HB11200101
NIH Device Record Keydcc397f0-8123-4f13-b5b8-4f29b958921c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTube Guard
Version Model NumberHB-112-0010
Company DUNS079282130
Company NameXENCO MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB064HB11200101 [Primary]

FDA Product Code

CBHDevice, Fixation, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-15
Device Publish Date2023-08-07

Devices Manufactured by XENCO MEDICAL LLC

B064HB11200101 - Tube Guard2023-08-15
B064HB11200101 - Tube Guard2023-08-15
B064MPE010101 - Saratoga Cervical Brace2023-08-15
B064MPE010401 - Tahiti Lumbar Brace2023-08-15
B064XM11510001 - Pedicle Screw Instruments Kit2022-08-19
B064XM12323451 - 23mm x 10mm PLIF Trial Kit 12, 13, 14, 15 mm Heights2020-04-06 23mm x 10mm PLIF Trials: 12, 13, 14, 15 mm Heights
B064XM12723451 - 27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights2020-04-06 27mm x 12mm TLIF Trials: 12, 13, 14, 15 mm Heights
B064XM12789011 - 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights2020-04-06
B064XM12823451 - 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights2020-04-06 28mm x 11mm Oblique Trial Kit 12, 13, 14, 15 mm Heights

Trademark Results [Tube Guard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TUBE GUARD
TUBE GUARD
73419446 1373145 Live/Registered
BRUSH & CO.
1983-03-28
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