SoftBiopsy

Basic Information

• Brand Name: SoftBiopsy
• Primary DI: 00860275000316
• Version / Model: SFT-1000
• Catalog Number: SFT-1000
• Company Name: HISTOLOGICS, LLC
• Labeler DUNS: 023001257
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-10
• Public Version: 2
• Public Version Date: 2021-07-19
• Public Version Status: Update
• Public Device Record Key: b81e7db9-14be-451e-84ee-ffa9bcdc9cf6

Device Description

Gynecological biopsy device for tissue collection, storage, and transport.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	884.4530	1
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

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
Package	10860275000313	GS1	Case	250	In Commercial Distribution
Primary	00860275000316	GS1

Customer Contacts

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