FDA.reportPublic FDA data

superDimension

Primary DI
10884521843172
Brand
superDimension
Company
Covidien LP
Model
AKI00100-01
Device description
Cytology Brush
Published
2023-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDXendoscopic cytology brush

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521843179PackageGS110In Commercial Distribution
10884521843172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452184317920884521843179
1088452184317210884521843172

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08
10884521543867SigniaSIGSBCHGR2017-08-01
10884521128927SonicisionSCST2016-09-24
10884521543829SigniaSIGADAPTSHORT2017-09-12

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
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
06970401810758Single 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