Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Endaural surgical curette, reusable FDA UDI
- Device Name
- Loop Electrode, 10mm x 8mm, Square, Sterile, Single-Use, BOX05, Unit of use FDA UDI
- Model / Reference
- 300-116 FDA UDI
- Description
- Loop Electrode, 10mm x 8mm, Square, Sterile, Single-Use, BOX05, Unit of use FDA UDI
Identifiers
- Catalog Number
- 300-116 FDA UDI
- Primary DI / UDI-DI
- 00840306828133 FDA UDI
- FDA Product Code
- JYQ FDA UDI
- GMDN Term
- Endaural surgical curette, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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 — 13 Centimeter FDA UDI
Category: Endaural surgical curette, reusable
Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endaural surgical curette, reusable.
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- BEAR — Bear-Ent, LLC · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- gSource — GSOURCE, LLC. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · 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 9de1e9e8-427e-4bb4-9891-a6b745d5c828 36 fields · synced Jun 8, 2026