Identity
- Trade Name
- PremierPro Vaginal Speculum FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- Vaginal Speculum, Lighted, Sterile, Size Small Disposal Methods: Disposal practices must be in compliance with all Federal, State and Local laws and regulations. DO NOT DUMP INTO ANY SEWERS, ON THE GROUND OR INTO ANY BODY OF WATER. FDA UDI
- Model / Reference
- 5340 FDA UDI
- Description
- Vaginal Speculum, Lighted, Sterile, Size Small Disposal Methods: Disposal practices must be in compliance with all Federal, State and Local laws and regulations. DO NOT DUMP INTO ANY SEWERS, ON THE GROUND OR INTO ANY BODY OF WATER. FDA UDI
Identifiers
- Catalog Number
- 5340 FDA UDI
- Primary DI / UDI-DI
- 00811220032227 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal speculum, single-use
PremierPro Vaginal Speculum by Svs Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Svs Llc
Sources (1)
- FDA UDI aa465ff5-1274-4872-8174-2883be12593a 35 fields · synced May 30, 2026