FDA.report

NA

Primary DI
04055207057674
Brand
NA
Company
Richard Wolf GmbH
Model
827830
Catalog number
8278.30
Device description
CYTOLOGY BRUSH
Published
2017-07-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
FDXendoscopic cytology brush

Product Code Classifications

CodeDeviceSpecialtyClass
FDXEndoscopic Cytology BrushGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207057674PrimaryGS10
04055207059586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207057674040552070576744055207057674
04055207059586040552070595864055207059586

GMDN Terms

TermDefinition
Flexible endoscopic cytology brush, reusableA 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 reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
5
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04055207068243VERTEBRIS89250643892506432026-02-10
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04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14953170466219Single Use Cytology Brush VOLYMPUS MEDICAL SYSTEMS CORP.FDX2026-01-19
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
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
06970401810857Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810864Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810871Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18