FDA.reportPublic FDA data

Single Use Cytology Brush

Primary DI
06970401810758
Brand
Single Use Cytology Brush
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-L-CB-2012-3010
Published
2023-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDXEndoscopic Cytology Brush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDXEndoscopic Cytology BrushGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220063000Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.2022-07-28FDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970401810758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970401810758069704018107586970401810758

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic cytology brush, single-useA device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936534328911Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810242026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810182026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815242026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815182026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825242026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825182026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410242026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410182026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415242026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415182026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425242026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425182026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810242026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810182026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815242026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815182026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825242026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825182026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410242026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410182026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170466212Single Use Cytology Brush VOLYMPUS MEDICAL SYSTEMS CORP.FDX2026-01-19
14953170466219Single Use Cytology Brush VOLYMPUS MEDICAL SYSTEMS CORP.FDX2026-01-19
00816207021751EndoTBrush Cytology BrushENDO-THERAPEUTICS, INC.FDX2024-04-18
10816207021758EndoTBrush Cytology BrushENDO-THERAPEUTICS, INC.FDX2024-04-18
00813353010295Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010301Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010318Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010325Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010332Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010349Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010356Disposable Bronchial Cytology BrushTelemed SystemsFDX2023-08-24
00813353010363Disposable Bronchial Cytology BrushTelemed SystemsFDX2023-08-24
10884521843219superDimensionCovidien LPFDX2023-07-22
20884521843216superDimensionCovidien LPFDX2023-07-22
10884521843172superDimensionCovidien LPFDX2023-07-21
20884521843179superDimensionCovidien LPFDX2023-07-21
06970401810703Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810710Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810727Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810734Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810741Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810765Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810772Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810789Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810796Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810802Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810819Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810826Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810833Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810840Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18