Disposable Gastrointestinal Cytology Brush

Basic Information

• Brand Name: Disposable Gastrointestinal Cytology Brush
• Primary DI: 00813353010318
• Version / Model: 3006
• Company Name: Telemed Systems
• Labeler DUNS: 017939239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-24
• Public Version: 1
• Public Version Date: 2023-09-01
• Public Version Status: New
• Public Device Record Key: f6228df2-e3e3-4507-9256-9d8ca4ff88de

Device Description

Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 1.8mm Catheter Diameter x 230cm Length

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38834	Flexible endoscopic cytology brush, single-use	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813353010318	GS1

Premarket Submissions

Submission Number	Supplement Number
K901435	000