Identity
- Trade Name
- Hern Dilator FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, reusable FDA UDI
- Device Name
- Hern Dilator 44Fr (14.6 mm) FDA UDI
- Model / Reference
- Hern Dilator 44Fr (14.6 mm) FDA UDI
- Description
- Hern Dilator 44Fr (14.6 mm) FDA UDI
Identifiers
- Catalog Number
- 030808 FDA UDI
- Primary DI / UDI-DI
- M803030808 FDA UDI
- FDA Product Code
- HDQ FDA UDI
- GMDN Term
- Fixed-diameter cervical dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Fixed-diameter cervical dilator, reusable
Hern Dilator by Medgyn Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medgyn Products, Inc.
Sources (1)
- FDA UDI 4d05d6c7-49cc-4c77-a09f-998fc35524cc 34 fields · synced Jun 8, 2026