FDA.reportPublic FDA data

Pediatric Bite Block

Primary DI
10677964060691
Brand
Pediatric Bite Block
Company
MEDIVATORS INC.
Model
100412
Published
2021-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNKEndoscopic Bite Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10677964060691PackageGS150In Commercial Distribution
20677964060698PackageGS12In Commercial Distribution
00677964060694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796406069110677964060691
2067796406069820677964060698
00677964060694006779640606946779640606940677964060694

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873custserv@medivators.com

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26
00677964153730Endo Carry-on Procedure Kit401123940112392026-05-26
00677964153747Endo Carry-on Procedure Kit401125140112512026-05-26
00677964153754Endo Carry-on Procedure Kit401125340112532026-05-26
00677964153761Endo Carry-on Procedure Kit401125440112542026-05-26
00677964153778Endo Carry-on Procedure Kit401136040113602026-05-26
00677964153785Endo Carry-on Procedure Kit401136140113612026-05-26
50677964153056Endo Carry-on Procedure Kit401104140110412026-03-12
50677964153063Endo Carry-on Procedure Kit401104240110422026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970800686855AltonAlton (Shanghai) Medical Instruments Co., Ltd.MNK2025-12-29
06973141950043EndocleanChangzhou Endoclean Medical Device Co.,LtdMNK2025-09-27
14897129991288CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
04897129991298CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
14897129991301CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
00194613120641MSI Precision Specialty InstrumentsMed Saver, Inc.MNK2025-08-01
16936603231125Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
00850025860048Breathe-EZMicro-tech UsaMNK2025-03-03
00858276007724Bite Block AdultMicro-tech UsaMNK2025-03-03
00858276007755Breathe-EZMicro-tech UsaMNK2025-03-03
06926839800595AnreiAnrei Medical(HZ) Co.,Ltd.MNK2025-01-07
40884389151151MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
16970057578269Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
14897129990755CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990762CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990724CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
00620974001072Bite BlockSouthmedic IncorporatedMNK2023-06-23
00620974001089Bite BlockSouthmedic IncorporatedMNK2023-06-23
00620974001683Bite BlockSouthmedic IncorporatedMNK2023-06-23
04719872108764Bite BlockENTER MEDICAL CORPORATIONMNK2023-06-19
06970401812165Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401812189Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401814077Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816132Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816149Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816156Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816538Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816828Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816835Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24