Omniflex Diaphragm

GUDID 00888937001082

Wide-Seal Silicone Vaginal Diaphragm; Size 95

Coopersurgical, Inc.

Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary Diaphragm pessary

• Primary Device ID: 00888937001082
• NIH Device Record Key: 60eb4ab8-596c-4db7-b1f2-3c86b7e01294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omniflex Diaphragm
• Version Model Number: MXWF95
• 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	00888937001082 [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