Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Bi-Polar Jeweler / Iris Forceps, Curved, 0.4m, Sterile, 10/PK FDA UDI
- Model / Reference
- 180-028 FDA UDI
- Description
- Bi-Polar Jeweler / Iris Forceps, Curved, 0.4m, Sterile, 10/PK FDA UDI
Identifiers
- Catalog Number
- 180-028 FDA UDI
- Primary DI / UDI-DI
- 10840306811941 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
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
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
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, reusable.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP. · Class II
- Bowel Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- AESCULAP — AESCULAP, INC. · Class II
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class II
- Silex — SILEX MEDICAL, LLC · Class II
- AESCULAP — AESCULAP, INC. · Class II
- Signature — SILEX MEDICAL, LLC · Class II
- Dorsey Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Marina Medical Instruments, Inc.
Sources (1)
- FDA UDI bee45a34-0f22-4f2b-af65-91481f775301 35 fields · synced May 30, 2026