Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- PRATT UTERINE DILATORS. SIZE 57-59FR FDA UDI
- Model / Reference
- 31-1450-012 FDA UDI
- Description
- PRATT UTERINE DILATORS. SIZE 57-59FR FDA UDI
Identifiers
- Catalog Number
- 31-1450-012 FDA UDI
- Primary DI / UDI-DI
- 00842180178090 FDA UDI
- FDA Product Code
- HDQ FDA UDI
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- Not 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
Elmed by Elmed Incorporated — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI d7bfed82-1013-4894-8480-3567caa09cc3 36 fields · synced May 31, 2026