Fisherbrand

Basic Information

• Brand Name: Fisherbrand
• Primary DI: 00613647000618
• Version / Model: 14959103
• Catalog Number: 14959103
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Labeler DUNS: 004321519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4b21cc22-b5b7-4b90-a62b-3764b7e6dc72

Device Description

FB ENDOCERVEX CYTO BRUSH 50/PK

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: Yes
• 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: 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
32368	Cervical cytology brush	A device with bristle-like projections designed to obtain a cervical biopsy of a suspicious area or visible exocervical lesions detected during a vaginal examination for the purpose of obtaining a tissue diagnosis from a woman with intraepithelial disease. It is inserted into the vagina and the head of the brush is firmly rotated over the area of interest until is covered with a bloody-mucoid sample. Some types may also have small bristles on a central protrusion that simultaneously enters the endocervical canal. The sample is secured in a cytology fixation solution or smeared onto a microscope slide for a Papanicolaou test (PAP). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613647000618	GS1
Unit of Use	10613647000615	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K001119	000