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Invotec Nasal Septal Button
FDA UDIEUDAMEDClass U (US FDA UDI)
Ref 20-10400Model Nasal Septal ButtonRef 20-10400S
Identity
- Trade Name
- Invotec Nasal Septal Button FDA UDI
- Generic Name
- Nasal septal button FDA UDI
- Device Name
- Nasal Septal Button EUDAMEDA device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration. FDA UDI
- Model / Reference
- Nasal Septal Button EUDAMED20-10400 EUDAMED20-10400S EUDAMED001 FDA UDI
- Description
- A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration. FDA UDI
Identifiers
- Catalog Number
- 20-10400S FDA UDI20-10400 FDA UDI
- Primary DI / UDI-DI
- 00818501020010 EUDAMEDFDA UDI00818501020003 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102SeptalButtonW9 EUDAMED
- 510(k) Number
- K901366 FDA UDI
- FDA Product Code
- LFB FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Nasal septal button FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal septal button
Invotec Nasal Septal Button by Invotec International, Inc. — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasal septal button.
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- Nasal Septal Button — Boston Medical Products, Inc. · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
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 U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (4)
- FDA UDI 053f02f1-7cce-4002-a30a-2706e911b198 35 fields · synced Jul 13, 2026
- FDA UDI be88536e-a101-4069-9fa3-e218609335a0 35 fields · synced May 30, 2026
- EUDAMED 132a5349-fad6-47e4-8d00-b4b88f22bf0c 61 fields · synced Jul 9, 2026
- EUDAMED ff740ee9-6ba9-448f-8693-91a6eb2e2458 61 fields · synced Jul 13, 2026