Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- WEISMAN PEDERSON VAGINAL SPECULUM, LEFT SIDE OPEN, 45 DEGREE HANDLE, MEDIUM - 4" X 7/8". FDA UDI
- Model / Reference
- 32-14-12A FDA UDI
- Description
- WEISMAN PEDERSON VAGINAL SPECULUM, LEFT SIDE OPEN, 45 DEGREE HANDLE, MEDIUM - 4" X 7/8". FDA UDI
Identifiers
- Catalog Number
- 32-14-12A FDA UDI
- Primary DI / UDI-DI
- 00019856058004 FDA UDI
- FDA Product Code
- HDF FDA UDI
- GMDN Term
- Vaginal speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI 392ee22e-ff3d-498d-8aef-1a29d937e83d 36 fields · synced Jun 6, 2026