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Soft-Form™ Thermo Plastic
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20-10121Ref 20-10101Ref 20-10100
Identity
- Trade Name
- Soft-Form™ Thermo Plastic EUDAMEDFDA UDISoft-Form™ Thermo Plastic External Nasal Splint FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Device Name
- External Nasal Splint EUDAMEDSoft-Form™ Thermo Plastic, Small FDA UDISoft-Form™ Thermo Plastic External Nasal Splint, Custom Cut FDA UDI
- Model / Reference
- 20-10101 EUDAMEDFDA UDI20-10100 EUDAMEDFDA UDI20-10121 EUDAMEDFDA UDI
- Description
- Soft-Form™ Thermo Plastic, Small FDA UDISoft-Form™ Thermo Plastic External Nasal Splint, Custom Cut FDA UDI
Identifiers
- Catalog Number
- 20-10101 FDA UDI20-10100 FDA UDI20-10121 FDA UDI
- Primary DI / UDI-DI
- 00818501022601 EUDAMEDFDA UDI00818501022434 EUDAMEDFDA UDI00818501022625 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 UDIFDA 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™ Thermo Plastic 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.
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- 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 (6)
- FDA UDI 4c1122d1-e758-439a-9d32-0c83c6a51246 34 fields · synced Jul 19, 2026
- FDA UDI 8e4972cb-1cfe-4f7f-8e70-17b07c9c90d2 34 fields · synced May 30, 2026
- FDA UDI 36c4c30d-2975-4163-b356-65cd8fe7edcd 34 fields · synced May 30, 2026
- EUDAMED 4590ae91-8fde-4a83-a6a4-2a3f2ddf38e1 61 fields · synced Jun 20, 2026
- EUDAMED c421a001-7a3f-482b-be62-38ddecbf70b4 61 fields · synced Jul 14, 2026
- EUDAMED dd7ab057-14cc-452c-a9e6-868324c28494 61 fields · synced Jul 19, 2026