FDA.reportPublic FDA data

Cleaning Brush

Primary DI
26970401813647
Brand
Cleaning Brush
Company
Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
Model
MD-D-BR-0510
Published
2018-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970401813633PackageGS150In Commercial Distribution
26970401813647PackageGS110In Commercial Distribution
06970401813629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181363316970401813633
2697040181364726970401813647
06970401813629069704018136296970401813629

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. 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
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
26970401813517Single Use Biopsy ForcepsMD-A-BF24232018-12-03

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