DISPOSABLE CYTOLOGY BRUSH

DISPOSABLE CYTOLOGY BRUSH - BC-17W

A 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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FBN

Device Name: Choledochoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with choledochoscope

Definition: to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: instrument guided laparoscopically or through the esophagus into the biliary tree

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: bile ducts

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170042789

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170042782

Package Quantity: 6

Package Discontinue Date: 6/23/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170042782

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A