Omniflex Diaphragm

Basic Information

• Brand Name: Omniflex Diaphragm
• Primary DI: 00888937001051
• Version / Model: MXWF80
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-15
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: b5c17253-ec72-47c7-8155-be17b8accba3

Device Description

Wide-Seal Silicone Vaginal Diaphragm; Size 80

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
HDW	Diaphragm, Contraceptive (And Accessories)	Obstetrics/Gynecology	884.5350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42405	Diaphragm pessary	A circular device made of soft rubber or plastic material that is placed in the vagina prior to intercourse to mechanically prevent conception. A spermicidal agent is typically placed within the device to add efficacy. This is a reusable device that should be checked and cleaned before reinsertion.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888937001051	GS1

Premarket Submissions

Submission Number	Supplement Number
K063223	000