Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Trucone Biopsy Electrode, 24mm x 15mm, Sterile, Single-Use, BOX05 FDA UDI
- Model / Reference
- 300-143 FDA UDI
- Description
- Trucone Biopsy Electrode, 24mm x 15mm, Sterile, Single-Use, BOX05 FDA UDI
Identifiers
- Catalog Number
- 300-143 FDA UDI
- Primary DI / UDI-DI
- 00840306828065 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
Dimensions & Sizes
- Size
- Length — 24 Millimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Marina Medical by Marina Medical Instruments, Inc. — 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
- Marina Medical Instruments, Inc.
Sources (1)
- FDA UDI 69a7b72d-206b-43ba-8478-a331989c4f3a 36 fields · synced Jun 1, 2026