Cytology Brush

Cytology Brush
superDimension - AKI00100-01

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

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 20884521200460

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521200463

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521200463

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