FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380070419
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
G4BB
Catalog number
G4BB
Device description
Cardinal Health; Endoscopic Bite Block; Adult Bite Block with Elastic Cloth Strap
Published
2019-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
50885380070417PackageGS150In Commercial Distribution
10885380070419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538007041750885380070417
1088538007041910885380070419

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
04897129991281CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
04897129991304CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
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
06936603231128Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
16936603231125Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
00850025860031Breathe-EZMicro-tech UsaMNK2025-03-03
00858276007717Bite Block AdultMicro-tech UsaMNK2025-03-03
00858276007748Breathe-EZMicro-tech UsaMNK2025-03-03
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
10884389151150MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
40884389151151MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
06970057578262Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
16970057578269Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
04897129990758CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
04897129990765CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990755CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990762CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
04897129990727CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
04897129990734CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990724CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
10620974001079Bite BlockSouthmedic IncorporatedMNK2023-06-23