FDA.report

Endoscopic bite block, basic, single-use

Definition
A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.
GUDID devices
130
Last updated
2026-01-06 15:15:24

Related Product Codes

CodeDeviceSpecialtyClassDevices
MNKEndoscopic Bite BlockGastroenterology, Urology1112
KTIBronchoscope AccessoryEar, Nose, Throat24
KBNGag, MouthEar, Nose, Throat13
KMJLubricant, PatientGeneral Hospital13
BRWProtector, DentalAnesthesiology12
FOGHood, Oxygen, InfantAnesthesiology12
CBHDevice, Fixation, Tracheal TubeAnesthesiology11
EGZHolder, Film, X-RayDental11
JAYSupport, Breathing TubeAnesthesiology11
PLAEsophageal Thermal Regulation And Gastric Suctioning DeviceCardiovascular21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
06970800686855AltonAlton (Shanghai) Medical Instruments Co., Ltd.AF-GBW2025-12-29
06973141950043EndocleanChangzhou Endoclean Medical Device Co.,LtdEDKN-004002/004006/004007/0040082025-09-27
04897129991298CeroFrictSML Med-Tech Solutions LimitedSML005-BB082025-08-11
14897129991288CeroFrictSML Med-Tech Solutions LimitedSML005-BB072025-08-11
14897129991301CeroFrictSML Med-Tech Solutions LimitedSML005-BB092025-08-11
00194613120641MSI Precision Specialty InstrumentsMed Saver, Inc.09-00542025-08-01
16936603231125Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdFTL-BB-AIII-W2025-06-23
00850025860048Breathe-EZMicro-tech UsaMDBB1AY003A2025-03-03
00858276007724Bite Block AdultMicro-tech UsaMDBB1AY001A2025-03-03
00858276007755Breathe-EZMicro-tech UsaMDBB1AY002A2025-03-03
06926839800595AnreiAnrei Medical(HZ) Co.,Ltd.AMH-BB-AY-012025-01-07
40884389151151MEDLINEMEDLINE INDUSTRIES, INC.MDS09640002024-09-20
16970057578269Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.VDK-KD-B12024-08-20
14897129990755CeroFrictSML Med-Tech Solutions LimitedSML005-BB052023-12-27
14897129990762CeroFrictSML Med-Tech Solutions LimitedSML005-BB062023-12-27
14897129990724CeroFrictSML Med-Tech Solutions LimitedSML005-BB03 2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedSML005-BB042023-10-24
B064HB11200101Tube GuardXENCO MEDICAL LLCHB-112-00102023-08-07
00620974001072Bite BlockSouthmedic IncorporatedETPSR-00A502023-06-23
00620974001089Bite BlockSouthmedic IncorporatedETPSR-00P502023-06-23
00620974001683Bite BlockSouthmedic IncorporatedETPSR3-00A502023-06-23
04719872108764Bite BlockENTER MEDICAL CORPORATIONPN-6002023-06-19
14897129990083CeroFrictSML Med-Tech Solutions LimitedSML005-BB012023-05-05
14897129990090CeroFrictSML Med-Tech Solutions LimitedSML005-BB022023-05-05
34026704743712RUSCHTELEFLEX INCORPORATEDIPN9245592023-04-04
26973881680167N/ATianjin Newtrans Technology Development1001-C2023-03-03
10860008457414SHEFA BlockShefa Solutions Inc.12022-04-29
14897106953568andorate® Bite Block 66Fr with Oxygen Connection and Tooth ProtectorGA Health Company LimitedGAR044F2022-02-23
14897106953582andorate® Bite Block 55.5Fr with StrapGA Health Company LimitedSDPC0209A2022-02-23
14897106953599andorate® Bite Block 66Fr with StrapGA Health Company LimitedSDPC02102022-02-23
00860007664205Remnova Complete Bite Block – AdultRemnova LLC12022-02-22
16932503560013MTMicro-Tech (Nanjing) Co., Ltd.AC01-103.A2021-12-31
16932503560020MTMicro-Tech (Nanjing) Co., Ltd.AC01-103.P2021-12-31
16932503560037MTMicro-Tech (Nanjing) Co., Ltd.AC01-107.M2021-12-31
16932503560044MTMicro-Tech (Nanjing) Co., Ltd.AC01-108.M2021-12-31
16932503560051MTMicro-Tech (Nanjing) Co., Ltd.AC01-109.M2021-12-31
00690521000056Batrik Bite Block/Single/No StrapBatrik Medical Manufacturing IncB02-N2021-10-29
00690521000179Batrik Bitestrong’/16mm/Ped/SingleBatrik Medical Manufacturing IncB1-N2021-10-29
00690521000230Batrik Bitestrong’/20mm/Adult/no dental retention rim/SingleBatrik Medical Manufacturing IncB3-NDR2021-10-29
00690521000247Batrik Bitestrong/20mm/Adult/ Single/without strapBatrik Medical Manufacturing IncB3-N 2021-10-29
00690521000261Batrik Bitestrong’/19mm/Single Batrik Medical Manufacturing IncB4T-N2021-10-29
00690521000339Batrik Bitestrong’/19mm/ReuseableBatrik Medical Manufacturing IncB6T-N2021-10-29
00690521000346Batrik Bitestrong’/19mm/ReuseableBatrik Medical Manufacturing IncB6T-N-252021-10-29
00690521015081Batrik Bitestrong'/20mm/Adult/Single/STRAP ATTACHEDBatrik Medical Manufacturing IncB3-SA2021-10-29
01200109414916Remnova Complete Bite Block - AdultRemnova LLC12021-10-20
10893029002530PediaBloc Endoscopy Bite BlockGI Supply, Inc.GIS-22021-07-07
10893029002547GeneraBloc Endoscopy Bite BlockGI Supply, Inc.GIS-32021-07-07
10893029002554UltimaBloc Endoscopy Bite BlockGI Supply, Inc.GIS-42021-07-07
10893029002561OmniBloc Endoscopy Bite BlockGI Supply, Inc.GIS-112021-07-07
10893029002523BlueBloc Endoscopy Bite BlockGI Supply, Inc.GIS-12021-07-06
14897106953551andorate® Bite Block 66Fr with Oxygen ConnectionGA Health Company LimitedGAR0442021-04-06
10724995183445E-Z GuardUS Endoscopy7101012021-03-31
10724995183452E-Z GuardUS Endoscopy7101032021-03-31
10724995184138NAUS Endoscopy007128012021-03-31
10724995184145NAUS Endoscopy007128022021-03-31
10724995184152NAUS Endoscopy007128032021-03-31
10724995184169NAUS Endoscopy007128042021-03-31
10724995184176NAUS Endoscopy007128052021-03-31
10724995184183NAUS Endoscopy007128062021-03-31
10724995184190NAUS Endoscopy007128082021-03-31
10724995184206NAUS Endoscopy007128092021-03-31
10724995184213VastoUS Endoscopy007128102021-03-31
10724995184220RespaUS Endoscopy007128112021-03-31
10724995184237NAUS Endoscopy007128122021-03-31
10677964060684Adult Bite BlockMEDIVATORS INC.1004112021-03-19
10677964060691Pediatric Bite BlockMEDIVATORS INC.1004122021-03-19
14897106953575andorate® Bite Block 55.5Fr with Strap and Tooth ProtectorGA Health Company LimitedSDPC02092021-03-12
14897106953605andorate® Bite Block 66Fr with Strap and Tooth ProtectorGA Health Company LimitedSDPC0210F2021-03-12
00849771043829Key Surgical Bite BlocksKEY SURGICAL, INC.EN-3002020-12-09
00849771043836Key Surgical Bite BlocksKEY SURGICAL, INC.EN-3102020-12-09
00849771043850Key Surgical Bite BlocksKEY SURGICAL, INC.EN-3202020-12-09
00849771043928Key Surgical Bite BlocksKEY SURGICAL, INC.EN-2102020-12-09
00690521000100Batrik Bitestrong Bite BlocksBatrik Medical Manufacturing IncBO22020-09-25
00690521000148Batrik Bitestrong Bite BlocksBatrik Medical Manufacturing IncBO2-R2020-09-25
00690521000186Batrik Bitestrong Bite BlocksBatrik Medical Manufacturing IncB12020-09-25
00690521000193Batrik Bitestrong Bite BlocksBatrik Medical Manufacturing IncB1-252020-09-25
00690521000223Batrik Bitestrong Bite BlocksBatrik Medical Manufacturing IncB3-NDR-N2020-09-25
00690521000254Batrik Bitestron Bite BlocksBatrik Medical Manufacturing IncB32020-09-25
00690521000278Batrik Bitestromg Bite BlocksBatrik Medical Manufacturing IncB4T2020-09-25
00690521000285Batrik Bitestrong Bite BlocksBatrik Medical Manufacturing IncB42020-09-25