Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Bone tack inserter, basic FDA UDI
- Device Name
- Miyazaki Tack Driver FDA UDI
- Model / Reference
- 337-240 FDA UDI
- Description
- Miyazaki Tack Driver FDA UDI
Identifiers
- Catalog Number
- 337-240 FDA UDI
- Primary DI / UDI-DI
- 00840306808142 FDA UDI
- FDA Product Code
- GEJ FDA UDI
- GMDN Term
- Bone tack inserter, basic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
MR Safe FDA UDI
Category: Bone tack inserter, basic
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 b2d12581-c031-40e7-a518-f4984e363316 35 fields · synced May 30, 2026