Identity
- Trade Name
- LMI IRRIGATION (STRAIGHT) CATHETER FDA UDI
- Generic Name
- Surgical irrigation/aspiration system FDA UDI
- Model / Reference
- 5FIGR80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B3805FIGR800 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Surgical irrigation/aspiration system
Lmi Irrigation (straight) Catheter by Lucas Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration system.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- ZOOM Aspiration Pump — Taiwan Biomaterial Co., Ltd. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Apollo System — PENUMBRA, INC. · Class II
- Apollo System — PENUMBRA, INC. · Class II
- Apollo System — PENUMBRA, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lucas Medical Inc
Sources (1)
- FDA UDI 877a962d-d8ab-4e97-b498-8a80d0a199f8 32 fields · synced May 30, 2026