FDA.reportPublic FDA data

NA

Primary DI
06941991310492
Brand
NA
Company
JIANGSU KANGJIN MEDICAL INSTRUMENT CO.,LTD
Model
Cleaning brush
Published
2023-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
16941991310499PackageGS110Not in Commercial Distribution
26941991310496PackageGS110In Commercial Distribution
06941991310492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694199131049916941991310499
2694199131049626941991310496
06941991310492069419913104926941991310492

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529632507
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941991310577NACleaning brush2023-03-31
06941991310591NACleaning brush2023-03-31
06941991310607NACleaning brush2023-03-31
06941991310614NACleaning brush2023-03-31
06941991310621NACleaning brush2023-03-31
06941991310638NACleaning brush2023-03-31
06941991310706NACleaning brush2023-03-31
06941991310720NACleaning brush2023-03-31
16941991310574NACleaning brush2023-03-31
16941991310598NACleaning brush2023-03-31
16941991310604NACleaning brush2023-03-31
16941991310611NACleaning brush2023-03-31
16941991310628NACleaning brush2023-03-31
16941991310635NACleaning brush2023-03-31
06941991310669NACleaning brush2023-03-31
16941991310703NACleaning brush2023-03-31
16941991310727NACleaning brush2023-03-31
16941991310499NACleaning brush2023-03-30

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Primary DI, Brand, Company table
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