Identity
- Trade Name
- Omniflex Diaphragm FDA UDI
- Generic Name
- Diaphragm pessary FDA UDI
- Device Name
- Wide-Seal Silicone Vaginal Diaphragm, Size 70 FDA UDI
- Model / Reference
- MXWF70 FDA UDI
- Description
- Wide-Seal Silicone Vaginal Diaphragm, Size 70 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937001037 FDA UDI
- 510(k) Number
- K063223 FDA UDI
- FDA Product Code
- HDW FDA UDI
- GMDN Term
- Diaphragm pessary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diaphragm pessary
Omniflex Diaphragm by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diaphragm pessary.
- Caya contoured diaphragm — KESSEL medintim GmbH · Class II
- Omniflex Diaphragm — CooperSurgical, Inc. · Class II
- Omniflex Diaphragm — CooperSurgical, Inc. · Class II
- Arcing Diaphragm — CooperSurgical, Inc. · Class II
- Arcing Diaphragm — CooperSurgical, Inc. · Class II
- Milex — CooperSurgical, Inc. · Class II
- Milex — CooperSurgical, Inc. · Class II
- Omniflex Diaphragm — CooperSurgical, Inc. · Class II
Cleared under the same submission
K063223 also covers:
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Arcing Diaphragm — CooperSurgical, Inc.
- Milex — CooperSurgical, Inc.
- Milex — CooperSurgical, Inc.
- Omniflex Diaphragm — CooperSurgical, Inc.
- Omniflex Diaphragm — CooperSurgical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 40e117f1-5de9-40ea-9324-f5602976648c 34 fields · synced Jun 9, 2026