DISPOSABLE CYTOLOGY BRUSH
DISPOSABLE CYTOLOGY BRUSH - BC-24Q
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FDX
Device Name: Endoscopic Cytology Brush
Device Class: 2
Physical State: brush and shaft
Definition: To collect cells for cytological evaluation.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Brush goes through endoscope to desired location and rotates to remove and collect cells.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: various tissues in gi and gu tract
Regulation Number: 876.1500
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170042833
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170042836
Package Quantity: 3
Package Discontinue Date: 4/1/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 04953170042836
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