Identity
- Trade Name
- OR-VAC EUDAMEDFDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- Non-orthopedic, Non-active, Accessory, Tubing/Connector, Smoke Evacuation, Sterile EUDAMEDOR-VAC Open Smoke Evacuation Tubing 7/8 in (22 mm) x 10 ft (3.1 m) with 8 in (20 cm) integral wand and sponge guard FDA UDI
- Model / Reference
- OL3MT24 EUDAMEDFDA UDI
- Description
- OR-VAC Open Smoke Evacuation Tubing 7/8 in (22 mm) x 10 ft (3.1 m) with 8 in (20 cm) integral wand and sponge guard FDA UDI
Identifiers
- Catalog Number
- OL3MT24 FDA UDI
- Primary DI / UDI-DI
- 20845854061852 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854061852 EUDAMED
- FDA Product Code
- GAZ FDA UDI
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Surgical plume evacuation system tube FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Or-Vac by Conmed Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20845854061852 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 2485e411-8e20-4e7f-8a8e-607a3b373be1 61 fields · synced Jun 19, 2026
- FDA UDI 0cef2614-9b0c-4bdd-bb7f-67bec2989e7f 35 fields · synced May 30, 2026
- EUDAMED 20bb47fa-05f4-40fb-aed2-e5529d64df2b 61 fields · synced Jun 19, 2026