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 Sinus Dressing SIZE: 2.5 cm x .9 cm x 2cm FDA UDI
- Model / Reference
- 22-60427 EUDAMEDFDA UDIPVA Packing EUDAMED
- Description
- PVA Sinus Dressing SIZE: 2.5 cm x .9 cm x 2cm FDA UDI
Identifiers
- Catalog Number
- 22-60427 FDA UDI
- Primary DI / UDI-DI
- 00818501022137 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
Similar devices
Also classified as Intranasal splint, non-biodegradable.
- Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet de 5 compresses — Adhe-Els SA. · Class I
- Intranasl Splint INS — Boston Medical Products, Inc. · Class I
- Sterile Gauze Balls — Kingstar Medical (Xianning) Co., LTD · Class I
- Sterile Absorbent Pads — GS Medical · Class I
- Sterile Gauze Sponges — JIANGSU FEIXIA MEDICAL PRODUCTS CO., LTD · Class I
- Sterile Pad 9cm x 15cm one fold Without X-Ray ETO sterile — ERMED TIP MEDİKAL TİCARET A.Ş. · Class IIa
- Gauze Swabs — Jiujiang HuaDa Medical Dressing Co., Ltd. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (2)
- FDA UDI 1dcf299a-2816-4256-a4cf-bef7844ba9be 34 fields · synced Jul 9, 2026
- EUDAMED b6c26831-511b-4ec6-b2ff-9b214739ba1a 61 fields · synced Jul 9, 2026