DISPOSABLE CYTOLOGY BRUSH - BC-201C-1006
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: True
Sterilization Methods:
- Ethylene Oxide
Product Codes
Code: EOB
Device Name: Nasopharyngoscope (Flexible Or Rigid)
Device Class: 2
Physical State: N/A
Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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: EN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 874.4760
Third Party Flag: Y
Medical Specialty: EN
Device Identifiers
Device Id: 14953170453752
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170453755
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04953170453755
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
