FDA.reportPublic FDA data

Disposable Bite Block

Primary DI
26970401813616
Brand
Disposable Bite Block
Company
Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
Model
MD-BB-AY-03
Published
2018-12-03
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
16970401813602PackageGS150In Commercial Distribution
26970401813616PackageGS15In Commercial Distribution
06970401813599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181360216970401813602
2697040181361626970401813616
06970401813599069704018135996970401813599

GMDN Terms#

Term, Definition table
TermDefinition
Suction system bottle/canister sealing setA sterile collection of items intended to be inserted into a suction system bottle/canister to facilitate air tightness of the container and maintain the vacuum. It typically includes synthetic polymer sealing rings and a plug. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16970401815095Disposable Valve SetsMD-B-AW012020-04-23
26970401814286Non-Rotatable SnaresMD-E-SNC2415242019-10-23
26970401814262Non-Rotatable SnaresMD-E-SNC2432242019-10-23
26970401814309Rotatable SnaresMD-E-SNR2415242019-10-23
26970401813739Cleaning BrushMD-A-BR-23062019-01-09
26970401813456Cleaning BrushMD-B-BR-23062018-11-23
26970401813470Cleaning BrushMD-B-BR-05102018-11-23
26970401813647Cleaning BrushMD-D-BR-05102018-12-10
26970401814248Single Use Biopsy ForcepsMD-B-BF24182019-09-25
26970401813975Single Use Biopsy ForcepsMD-C-BF24032019-06-04
26970401814002Single Use Grasping ForcepsMD-C-GF24032019-06-04
26970401813944Single Use Biopsy ForcepsMD-A-BF24182019-04-29
26970401812862Single Use HemoclipMD-L-HR-270-15-135-Y2019-03-22
26970401813913Single Use GuidewireMD-S-GW35452019-03-23
26970401813890Single Use HemoclipMD-C-HR-270-13-135-Y2019-03-22
26970401813401Single Use Biopsy ForcepsMD-A-BF24162019-02-26
26970401813845Disposable Bite BlockMD-BB-CY-012019-02-26
26970401813210Rotatable SnaresMD-E-SNR2432242018-09-25
26970401813715Single Use HemoclipMD-G-HR-230-12-135-N2019-01-08
16970401813671Single Use Biopsy ForcepsMD-B-BF24232019-01-04

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