FemCap

Basic Information

• Brand Name: FemCap
• Primary DI: 00863008000102
• Version / Model: 22 mm small
• Catalog Number: 70-399-22
• Company Name: FEMCAP, INC.
• Labeler DUNS: 140036166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5cd92fc8-e41d-4ece-adb1-10df246c9e34

Device Description

FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.

Device Characteristics

• Single Use: No
• 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
LLQ	Cap, Cervical, Contraceptive	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46971	Contraceptive cervical cap, reusable	A contraceptive device that is inserted into the cervix where it acts as a physical barrier to prevent semen from entering the uterus. It is typically a soft rubber cup with a round rim that is sized by a healthcare professional to fit snugly around the cervix. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863008000102	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			22 mm