Histobrush® Cytology Brush

Basic Information

• Brand Name: Histobrush® Cytology Brush
• Primary DI: 30609576250089
• Version / Model: 2188
• Catalog Number: 2188
• Company Name: Puritan Medical Products
• Labeler DUNS: 001101419
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 4
• Public Version Date: 2020-08-26
• Public Version Status: Update
• Public Device Record Key: fc6b8523-5e6c-4180-8df0-74b16cde9fcf

Device Description

Histobrush 8” Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 2188

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42537	Cytology scraper, single-use	A wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50609576250083	GS1		1000	In Commercial Distribution
Primary	30609576250089	GS1
Unit of Use	00609576250088	GS1

Premarket Submissions

Submission Number	Supplement Number
K111681	000