Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Wire/ligature passer, reusable FDA UDI
- Device Name
- Miyazaki Ligature Carrier, small hook, Ø0.5", 20cm / 8" FDA UDI
- Model / Reference
- 337-200SH FDA UDI
- Description
- Miyazaki Ligature Carrier, small hook, Ø0.5", 20cm / 8" FDA UDI
Identifiers
- Catalog Number
- 337-200SH FDA UDI
- Primary DI / UDI-DI
- 00840306808135 FDA UDI
- FDA Product Code
- GEJ FDA UDI
- GMDN Term
- Wire/ligature passer, reusable 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
Dimensions & Sizes
- Size
- Length — 8 Inch FDA UDI
Category: Wire/ligature passer, reusable
Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Ambler Surgical — Ambler Surgical, LLC · Class I
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 46c0bbfb-d52b-4d32-bcc1-41cf8d6001f3 36 fields · synced May 29, 2026