FDA.report

NA

Primary DI
10653405052296
Brand
NA
Company
Conmed Corporation
Model
163R
Catalog number
163R
Device description
MILL-ROSE CYTOLOGY BRUSH
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FDXendoscopic cytology brush

Product Code Classifications

CodeDeviceSpecialtyClass
FDXEndoscopic Cytology BrushGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653405052296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1065340505229610653405052296

GMDN Terms

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

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
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

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Primary DIBrandCompanyProduct codePublished
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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
20884521843216superDimensionCovidien LPFDX2023-07-22
20884521843179superDimensionCovidien LPFDX2023-07-21
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06970401810710Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
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06970401810734Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
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06970401810789Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
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