FDA.report

Disposable Bite Block

Primary DI
06970401812165
Brand
Disposable Bite Block
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-BB-AN-01
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

Related Records

Product Codes

CodeName
MNKEndoscopic Bite Block

Product Code Classifications

CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06970401812165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06970401812165069704018121656970401812165

GMDN Terms

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

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 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

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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
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14897129990755CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
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14897129990724CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
00620974001072Bite BlockSouthmedic IncorporatedMNK2023-06-23
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00620974001683Bite BlockSouthmedic IncorporatedMNK2023-06-23
04719872108764Bite BlockENTER MEDICAL CORPORATIONMNK2023-06-19
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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