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Speculum Tubing
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ICM-000-0027Ref ICM-000-0021
Identity
- Trade Name
- Speculum Tubing EUDAMEDFDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- I/A Tubing EUDAMEDSmoke Accessories Non-Sterile EUDAMED
- Model / Reference
- ICM-000-0021 EUDAMEDFDA UDIICM-000-0027 EUDAMEDFDA UDIICM-000-0365 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817688021353 EUDAMEDFDA UDI00817688021377 EUDAMEDFDA UDI00817688021391 FDA UDI
- Basic UDI-DI
- 081768802SmokeAccessS55 EUDAMED081768802SmokeAccessNS6J EUDAMED
- FDA Product Code
- GEX 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
- 878.4810 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA 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
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Ethylene Oxide FDA UDI
Category: Surgical plume evacuation system tube
Speculum Tubing by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical plume evacuation system tube.
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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 (5)
- FDA UDI 4f274d32-977d-453f-a3b9-c929a4a59d74 32 fields · synced Oct 6, 2026
- FDA UDI d77a4298-cbd3-46a7-ae92-f7191cf57329 32 fields · synced May 30, 2026
- FDA UDI 7738aa24-6ded-4c07-84df-33c3a79c4d66 32 fields · synced May 30, 2026
- EUDAMED 790ca0aa-7a11-4149-823a-a758ac1c78a7 61 fields · synced Jul 22, 2026
- EUDAMED d2f87290-37ff-4f54-a22d-ef2a1efea85d 61 fields · synced Jul 27, 2026