Identity
- Trade Name
- Soft-Form™ AL External Nasal Splint FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Device Name
- Soft-Form™ AL External Nasal Splint, Regular FDA UDI
- Model / Reference
- 20-10210 FDA UDI
- Description
- Soft-Form™ AL External Nasal Splint, Regular FDA UDI
Identifiers
- Catalog Number
- 20-10210 FDA UDI
- Primary DI / UDI-DI
- 00818501022489 FDA UDI
- FDA Product Code
- EPP FDA UDI
- GMDN Term
- External nasal splint FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (1)
- FDA UDI 954f3b56-36ab-4aaf-a92f-2b6bbc30be22 34 fields · synced Jun 9, 2026