Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Vascular dilator, reusable FDA UDI
- Device Name
- Redundant Wall Retractor (RWR), 9cm x 2cm 8.9 X 1.9cm Blades, 18cm/7in NC Coating FDA UDI
- Model / Reference
- 250-619NC FDA UDI
- Description
- Redundant Wall Retractor (RWR), 9cm x 2cm 8.9 X 1.9cm Blades, 18cm/7in NC Coating FDA UDI
Identifiers
- Catalog Number
- 250-619NC FDA UDI
- Primary DI / UDI-DI
- 00840306825071 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Vascular dilator, 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
Dimensions & Sizes
- Size
- Length — 7 Inch FDA UDI
Category: Vascular dilator, reusable
Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
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- Avalign — AVALIGN TECHNOLOGIES, 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 ed28b4a1-c415-4187-90ca-1f69f03313a4 36 fields · synced Jun 1, 2026