Softdisc

Basic Information

• Brand Name: Softdisc
• Primary DI: 00851906007477
• Version / Model: Softdisc 5 count bag (English only)
• Company Name: The Flex Company
• Labeler DUNS: 080314616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 14
• Record Status: Published
• Publish Date: 2021-03-22
• Public Version: 3
• Public Version Date: 2022-08-03
• Public Version Status: Update
• Public Device Record Key: 377dd6ee-1249-4094-ba16-d3ffe1b2b98a

Device Description

Softdisc 5 count bag (English only)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHE	Cup, Menstrual	Obstetrics/Gynecology	884.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47723	Menstrual cup, non-latex, single-use	A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device typically made of a biocompatible synthetic materials (e.g., low density polyethylene) and is typically removed from the vagina by pulling on a protruding stem or by insertion of a finger to catch its rim; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00851906007002	GS1
Primary	00851906007477	GS1
Package	10851906007474	GS1		18	In Commercial Distribution

Customer Contacts

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