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Silicone Tubing
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 50-01181Model Silicone Tubing - Non-Sterile
Identity
- Trade Name
- Silicone Tubing FDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Silicone Tubing - Non-Sterile EUDAMEDSilicone Tubing 0.078" X 0.125" FDA UDI
- Model / Reference
- 50-01181 EUDAMEDFDA UDISilicone Tubing - Non-Sterile EUDAMED
- Description
- Silicone Tubing 0.078" X 0.125" FDA UDI
Identifiers
- Catalog Number
- 50-01181 FDA UDI
- Primary DI / UDI-DI
- 00818501023011 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102NSSiliconetubeVL EUDAMED
- FDA Product Code
- GAZ FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Suction/irrigation tubing, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suction/irrigation tubing, single-use
Silicone Tubing by Invotec International, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
- Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
- AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
- Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
- Bioseal Inc. — BIOSEAL · Class I
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
- Invotec International, Inc.
Sources (2)
- FDA UDI 7615f1cb-9389-46ef-8459-e340eecad81c 34 fields · synced Aug 2, 2026
- EUDAMED eacbe448-4401-41e7-8e10-33e06377f2b3 61 fields · synced Aug 2, 2026