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Soft-Form™ AL External Nasal Splint
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20-10221
Identity
- Trade Name
- Soft-Form™ AL Aluminum EUDAMEDSoft-Form™ AL External Nasal Splint FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Device Name
- External Nasal Splint EUDAMEDSoft-Form™ AL External Nasal Splint, Large FDA UDI
- Model / Reference
- 20-10221 EUDAMEDFDA UDI
- Description
- Soft-Form™ AL External Nasal Splint, Large FDA UDI
Identifiers
- Catalog Number
- 20-10221 FDA UDI
- Primary DI / UDI-DI
- 00818501022564 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102ExtNasalSplintRD EUDAMED
- FDA Product Code
- EPP FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- External nasal splint FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.5800 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
Yes
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
Category: External nasal splint
Soft-Form™ AL External Nasal Splint by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External nasal splint.
- ENTPROMED — ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- External aluminium nasal splint — Spiggle & Theis Medizintechnik GmbH · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- BRIDGEMASTER™ — MEDTRONIC XOMED, INC. · Class I
- Aquaplast PS™ — Qfix · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- Equipment box for external nasal splints — Spiggle & Theis Medizintechnik GmbH · 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 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 28a553a9-5d49-4e70-a216-ae9a7e291588 34 fields · synced Jul 12, 2026
- EUDAMED c9a0b79a-df6c-4b9b-b14a-5f2e1d8b2120 61 fields · synced Jul 12, 2026