Identity
- Trade Name
- DEFINITY CERVICAL DILATOR, 7MM FDA UDI
- Generic Name
- Cervical dilatation catheter FDA UDI
- Model / Reference
- DCD-701 FDA UDI
Identifiers
- Catalog Number
- DCD-701 FDA UDI
- Primary DI / UDI-DI
- 15420045512429 FDA UDI
- FDA Product Code
- PON FDA UDI
- GMDN Term
- Cervical dilatation catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4260 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
Ethylene Oxide FDA UDI
Definity Cervical Dilator, 7mm by Hologic, 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
- Hologic, Inc.
Sources (1)
- FDA UDI eb1bf532-d9a8-4175-b89b-7b66910dde0f 35 fields · synced May 30, 2026