Identity
- Trade Name
- Pro-Ception Fertlity Paks FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- Small (1 3/4"); 1 Box equals 12 units as quantity FDA UDI
- Model / Reference
- MXFEPAK FDA UDI
- Description
- Small (1 3/4"); 1 Box equals 12 units as quantity FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20888937000997 FDA UDI
- FDA Product Code
- HDR FDA UDI
- GMDN Term
- Assisted reproduction transfer catheter/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pro-Ception Fertlity Paks by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 002028d8-76fc-4052-b25d-7f07c8a4c99c 34 fields · synced Jun 9, 2026