Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- Speculum, Graves, Laser, Large, 12cm x 4cm, Smoke Tube FDA UDI
- Model / Reference
- 380-102 FDA UDI
- Description
- Speculum, Graves, Laser, Large, 12cm x 4cm, Smoke Tube FDA UDI
Identifiers
- Catalog Number
- 380-102 FDA UDI
- Primary DI / UDI-DI
- 00840306836688 FDA UDI
- FDA Product Code
- HDF FDA UDI
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Centimeter FDA UDI
Category: Vaginal speculum, single-use
Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Marina Medical Instruments, Inc.
Sources (1)
- FDA UDI 8b625645-a460-4ce7-8f4e-0f9f14b1302f 36 fields · synced May 31, 2026