FDA.reportPublic FDA data

Disposable Bite Block

Primary DI
06936603235140
Brand
Disposable Bite Block
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-BB-P-W
Catalog number
MP-03-30-33-R
Device description
Yellow pediatric bite block with 55 cm green rubber strap
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
16936603235147PackageGS1100In Commercial Distribution
26936603235144PackageGS14In Commercial Distribution
06936603235140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323514716936603235147
2693660323514426936603235144
06936603235140069366032351406936603235140

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
544375774
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936603211625Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-RCPS-CR-24-02-10-2302026-10-22
06936603211649Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-NCPS-CS-24-02-10-2302026-10-22
06936603211724Disposable Polypectomy SnareFTL-PS-24-230-10-O-NSOV-DS-23-10-2302026-10-22
06936603211908Disposable Biopsy ForcepsFTL-BF-18-180-O-O-RTC11-ECO-S-18-180-SU2026-10-22
06936603211953Disposable Biopsy ForcepsFTL-BF-30-230-O-O-RTC11-ECO-30-230-SU2026-10-22
06936603211977Disposable Biopsy ForcepsFTL-BF-23-180-O-O-RTC11-SJ-23-180-SU2026-10-22
06936603212059Disposable Biopsy ForcepsFTL-BF-18-180-W-O-RTC12-ECO-S-18-180-SU2026-10-22
06936603212103Disposable Biopsy ForcepsFTL-BF-30-230-W-O-RTC12-ECO-30-230-SU2026-10-22
06936603212196ECO InjectFTL-IN-24-230-22-4IHN-23-22-4-2302026-10-22
06936603212202ECO InjectFTL-IN-24-230-22-5IHN-23-22-5-2302026-10-22
06936603212219ECO InjectFTL-IN-24-230-22-6IHN-23-22-6-2302026-10-22
06936603212240ECO InjectFTL-IN-24-230-23-4IHN-23-23-4-2302026-10-22
06936603212257ECO InjectFTL-IN-24-230-23-5IHN-23-23-5-2302026-10-22
06936603212271ECO InjectFTL-IN-24-230-25-5IHN-23-25-5-2302026-10-22
06936603212288ECO InjectFTL-IN-24-230-25-4IHN-23-25-4-2302026-10-22
06936603212295ECO InjectFTL-IN-24-230-25-6IHN-23-25-6-2302026-10-22
06936603212301Clean Connecting TubeFTL-EFC-IT-ETSIT-ETS-2102026-10-22
06936603212318Clean Connecting TubeFTL-EFC-IT-STD-FSIT-OUS-2102026-10-22
06936603212424Clean Connecting TubeFTL-EFC-O-H2-B1WBUC-HYB-OL42026-10-22
06936603212448Clean Connecting TubeFTL-EFC-O-S-B1WBUC-OL2-NC22026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603234938Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
06936603235157Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
06936603235164Disposable Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2026-10-22
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