Invotec Silicone Sheeting
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Invotec Silicone Sheeting FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- Silicone Sheeting - Non-Sterile EUDAMEDInvotec Silicone Sheeting, 12 X 12 X 0.0025" FDA UDI
- Model / Reference
- 20-30002 EUDAMEDFDA UDISilicone Sheeting - Non-Sterile EUDAMED
- Description
- Invotec Silicone Sheeting, 12 X 12 X 0.0025" FDA UDI
Identifiers
- Catalog Number
- 20-30002 FDA UDI
- Primary DI / UDI-DI
- 00818501021208 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102NSSiliconePB EUDAMED
- FDA Product Code
- LYA FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Intranasal splint, non-biodegradable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4780 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Intranasal splint, non-biodegradable
Invotec Silicone Sheeting by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intranasal splint, non-biodegradable.
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- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (2)
- FDA UDI 1835a554-0623-4291-a107-2dea3e99e687 34 fields · synced Aug 3, 2026
- EUDAMED b45eeaaa-fdef-49d7-b11b-58228330c3eb 61 fields · synced Aug 3, 2026