FDA.reportPublic FDA data

Endoclean

Primary DI
06973141950043
Brand
Endoclean
Company
Changzhou Endoclean Medical Device Co.,Ltd
Model
EDKN-004002/004006/004007/004008
Published
2025-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MNKEndoscopic Bite Block
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973141950043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973141950043069731419500436973141950043

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
705006876
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973141950173EndocleanEDKN-0020012026-04-29
06973141950319EndocleanEDKN-004005/004006/004013/0040142026-04-29
06973141950302EndocleanEDKN-004006/004013/0040142026-04-28
00697314195036EndocleanEDKN-004006/004007/0040082025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
00724995247300NAMEDIVATORS INC.ODC2026-03-02
00858276007984Endoscopy Kit - Compliance+ FUJ5 KitMicro-tech UsaODC2025-05-12
008500258605674-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860642Auxiliary Water ConnectorMicro-tech UsaODC2025-03-04
00850025860659Auxiliary Water ConnectorMicro-tech UsaODC2025-03-04
00850025860673Auxiliary Water ConnectorMicro-tech UsaODC2025-03-04
008500258606805-Piece Valve KitMicro-tech UsaODC2025-03-04
008500258607104-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860741Disposable Biopsy ValveMicro-tech UsaODC2025-03-04
008500258607583-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860765Disposable Biopsy ValveMicro-tech UsaODC2025-03-04
008500258608713-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860888Endoscopy Kit - Basic w Aux WaterMicro-tech UsaODC2025-03-04
00858276007793Jacket Air/Water & Suction Valve KitMicro-tech UsaODC2025-03-04