Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- Sims Speculum, Medium, Double-Ended, 3cm x 7.5cm, 4cm x 8.5cm (NC COATING) FDA UDI
- Model / Reference
- 254-002NC FDA UDI
- Description
- Sims Speculum, Medium, Double-Ended, 3cm x 7.5cm, 4cm x 8.5cm (NC COATING) FDA UDI
Identifiers
- Catalog Number
- 254-002NC FDA UDI
- Primary DI / UDI-DI
- 00840306825385 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
- 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 — 8.5 Centimeter FDA UDI
Category: Vaginal speculum, reusable
Marina Medical by Marina Medical Instruments, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Marina Medical Instruments, Inc.
Sources (1)
- FDA UDI 32269e0e-95fc-4538-b93e-c51c77ad61a7 36 fields · synced May 31, 2026