Identity
- Trade Name
- Mityvac FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- MitySoft Bell Cup with Universal Vacuum Release (UVR) Vacuum-Assist Delivery System FDA UDI
- Model / Reference
- 10021 FDA UDI
- Description
- MitySoft Bell Cup with Universal Vacuum Release (UVR) Vacuum-Assist Delivery System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937003086 FDA UDI
- FDA Product Code
- HDB FDA UDI
- GMDN Term
- Foetal vacuum extraction system cup, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mityvac by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 0432b39f-86e4-4d5c-b57f-d4ff7636479c 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026