Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MT Otology Packing Strips EUDAMEDCustom Cut Silicone Sheeting For Internal Nasal Splints & Packing FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- Otology Packing Strips - Silicone EUDAMEDCustom Cut Silicone Sheeting For Internal Nasal Splints & Packing 1.60" X 0.24" X 0.005" FDA UDI
- Model / Reference
- 27-10001 EUDAMEDFDA UDI
- Description
- Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing 1.60" X 0.24" X 0.005" FDA UDI
Identifiers
- Catalog Number
- 27-10001 FDA UDI
- Primary DI / UDI-DI
- 00818501020881 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102SiliconeSheetSV 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
Yes
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Intranasal splint, non-biodegradable
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Intranasal splint, non-biodegradable.
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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 1e69f74b-689a-4a8b-8c8d-e4fbdb66797b 34 fields · synced Jul 12, 2026
- EUDAMED 5b8641e1-42af-489f-a752-82ac4cea96d4 61 fields · synced Jun 14, 2026