Identity
- Trade Name
- CVX-RIPE FDA UDI
- Generic Name
- Cervical dilatation catheter FDA UDI
- Device Name
- Double-balloon cervical dilatation catheter for cervical ripening FDA UDI
- Model / Reference
- CVX-100 FDA UDI
- Description
- Double-balloon cervical dilatation catheter for cervical ripening FDA UDI
Identifiers
- Catalog Number
- CVX-100 FDA UDI
- Primary DI / UDI-DI
- H671CVX1000 FDA UDI
- 510(k) Number
- K143424 FDA UDI
- FDA Product Code
- PFJ FDA UDI
- GMDN Term
- Cervical dilatation catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4260 FDA UDI
- Commercial Distribution
- 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
Category: Cervical dilatation catheter
Cvx-Ripe by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical dilatation catheter.
- Prepidil® Gel, dinoprostone cervical gel — Pharmacia & Upjohn Co.
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
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
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI c3d8b4bf-dbc7-4046-a239-3ec2424551d0 36 fields · synced Jun 9, 2026