Pro-Ception Oligospermia Cup

Basic Information

• Brand Name: Pro-Ception Oligospermia Cup
• Primary DI: 00888937000511
• Version / Model: MXFOC36
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-28
• Public Version: 4
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: f60640ee-36ec-462f-84f7-420efa5be7ed

Device Description

Without Stem - 36mm cup

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
HDR	Cap, Cervical	Obstetrics/Gynecology	884.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32608	Contraceptive cervical cap, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937000515	GS1		5	In Commercial Distribution
Primary	00888937000511	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			36mm