Omniflex Diaphragm

GUDID 00888937001051

Wide-Seal Silicone Vaginal Diaphragm; Size 80

Coopersurgical, Inc.

Diaphragm pessary

• Primary Device ID: 00888937001051
• NIH Device Record Key: b5c17253-ec72-47c7-8155-be17b8accba3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omniflex Diaphragm
• Version Model Number: MXWF80
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937001051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063223

FDA Product Code

• HDW: Diaphragm, Contraceptive (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-15

On-Brand Devices [Omniflex Diaphragm]

• 00888937001082: Wide-Seal Silicone Vaginal Diaphragm; Size 95
• 00888937001075: Wide-Seal Silicone Vaginal Diaphragm; Size 90
• 00888937001068: Wide-Seal Silicone Vaginal Diaphragm; Size 85
• 00888937001051: Wide-Seal Silicone Vaginal Diaphragm; Size 80
• 00888937001044: Wide-Seal Silicone Vaginal Diaphragm; Size 75
• 00888937001037: Wide-Seal Silicone Vaginal Diaphragm, Size 70
• 00888937001020: Wide-Seal Silicone Vaginal Diaphragm, Size 65
• 00888937001013: Wide-Seal Silicone Vaginal Diaphragm; Size 60