Soft-ECC

Basic Information

• Brand Name: Soft-ECC
• Primary DI: 00860275000323
• Version / Model: SFT-2000
• Catalog Number: SFT-2000
• 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: 1
• Public Version Date: 2019-11-18
• Public Version Status: New
• Public Device Record Key: b0376379-be5a-439b-9870-633728063ce0

Device Description

Endocervical curette system 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
HCY	Curette, Uterine	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57938	Endocervical specimen collection kit	A collection of devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation. It typically includes a swab, brush, spatula, and/or other collection devices and a transport container (with or without additives). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860275000320	GS1	Case	250	In Commercial Distribution
Primary	00860275000323	GS1

Customer Contacts

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