Identity
- Trade Name
- PremierPro FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- PremierPro Vaginal Speculum, Lighted, Medium FDA UDI
- Model / Reference
- 5311 FDA UDI
- Description
- PremierPro Vaginal Speculum, Lighted, Medium FDA UDI
Identifiers
- Catalog Number
- 5311 FDA UDI
- Primary DI / UDI-DI
- 20818566017479 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal speculum, single-use
PremierPro by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal speculum, single-use.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- AMSure® Disposable Vaginal Speculum — AMSINO INTERNATIONAL, INC. · Class II
- Centurion — Centurion Medical Products · Class II
- Vaginal Speculum — Dynarex Corp. · Class II
- Sklar — Sklar Corporation · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
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 21a87dcf-7a8a-4c6c-bee6-e77028841b95 35 fields · synced Jun 8, 2026