Identity
- Trade Name
- Smoke Tubing EUDAMEDFDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- I/A Tubing EUDAMED
- Model / Reference
- ICM-000-0098 EUDAMEDFDA UDIICM-000-0347 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817688021513 EUDAMEDFDA UDI00817688021575 FDA UDI
- Basic UDI-DI
- 081768802SmokeAccessS55 EUDAMED
- FDA Product Code
- FYD FDA UDI
- EMDN Code
- Z12019085 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - CONSUMABLES EUDAMED
- GMDN Term
- Surgical plume evacuation system tube FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Surgical plume evacuation system tube
Smoke Tubing by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- I.C. Medical, Inc.
Sources (3)
- FDA UDI 2d4520d7-7f70-4365-a8c2-1f04e742dfb4 32 fields · synced Jul 8, 2026
- FDA UDI 7117c07a-c17b-4cc1-a073-02f45505103d 32 fields · synced May 30, 2026
- EUDAMED 94b2e356-320c-44bc-9240-5f4f4c4ede2f 61 fields · synced Jul 8, 2026