Invotec PVA Nasal Dressing
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Invotec PVA Nasal Dressing FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- PVA Packing EUDAMEDPVA Anatomical Nasal Tampon Slimline SIZE: 8.0 cm x .75 cm x 3 cm FDA UDI
- Model / Reference
- 22-60414 EUDAMEDFDA UDIPVA Packing EUDAMED
- Description
- PVA Anatomical Nasal Tampon Slimline SIZE: 8.0 cm x .75 cm x 3 cm FDA UDI
Identifiers
- Catalog Number
- 22-60414 FDA UDI
- Primary DI / UDI-DI
- 00818501022090 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102PVAPackingYA EUDAMED
- FDA Product Code
- NAB 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
- 878.4014 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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Intranasal splint, non-biodegradable
Invotec PVA Nasal Dressing by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 20140fea-4b02-426f-8c13-65830a7b2d68 34 fields · synced Jun 19, 2026
- EUDAMED 74582441-49ca-4617-aa6d-146e37612fe9 61 fields · synced Jun 19, 2026