FDA.reportPublic FDA data

Disposable Bite Block

Primary DI
06970401816132
Brand
Disposable Bite Block
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-BB-AN-02
Published
2023-05-24
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
06970401816132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970401816132069704018161326970401816132

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
06970401812240Polyp TrapMD-A-PT702018-12-10
06936534331614Polyp TrapMD-B-PT052024-07-22
06970401816910Polyp TrapMD-A-PT402024-07-22
06970401814039Polyp TrapMD-A-PT702021-03-01
06936534332260Air/Water Bottle TubingMD-B-SE-702122023-12-18
06936534338675Endoscopy Irrigation TubingMD-A-IT-30002023-12-18
06936534338682Endoscopy Irrigation TubingMD-B-IT-18802023-12-18
06936534325439Single Use Urinary GuidewireMD-A1-UW21182023-11-27
06936534325446Single Use Urinary GuidewireMD-A1-UW21202023-11-27
06936534325453Single Use Urinary GuidewireMD-A1-UW21262023-11-27
06936534325460Single Use Urinary GuidewireMD-A1-UW25052023-11-27
06936534325477Single Use Urinary GuidewireMD-A1-UW25102023-11-27
06936534325484Single Use Urinary GuidewireMD-A1-UW25122023-11-27
06936534325491Single Use Urinary GuidewireMD-A1-UW25152023-11-27
06936534325507Single Use Urinary GuidewireMD-A1-UW25182023-11-27
06936534325514Single Use Urinary GuidewireMD-A1-UW25202023-11-27
06936534325521Single Use Urinary GuidewireMD-A1-UW25262023-11-27
06936534325538Single Use Urinary GuidewireMD-A1-UW28052023-11-27
06936534325545Single Use Urinary GuidewireMD-A1-UW28102023-11-27
06936534325552Single Use Urinary GuidewireMD-A1-UW28122023-11-27

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
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
14897129990083CeroFrictSML Med-Tech Solutions LimitedMNK2023-05-05