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Nasal Septal Perforation Prosthesis, Oval, 13mm x 17mm x 3mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref SP 2133
Identity
- Trade Name
- Nasal Septal Perforation Prosthesis, Oval, 13mm x 17mm x 3mm EUDAMEDInHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Nasal septal button FDA UDI
- Device Name
- SEPTAL EUDAMED
- Model / Reference
- SP 2133 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848253002170 EUDAMEDFDA UDI
- Basic UDI-DI
- 08482530SEPTALNL EUDAMED
- FDA Product Code
- LFB FDA UDI
- EMDN Code
- P020201 NASAL SEPTAL PLUGGERS EUDAMED
- GMDN Term
- Nasal septal button FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Nasal Septal Perforation Prosthesis, Oval, 13mm x 17mm x 3mm by Freudenberg Medical LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08482530SEPTALNL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Freudenberg Medical LLC
- EUDAMED SRN
- US-MF-000023823
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9b93ab4a-be08-40c7-b62d-fa246675f5d6 61 fields · synced Jun 19, 2026
- FDA UDI 2cb24396-14d5-47ef-bef3-661899c4e54c 34 fields · synced May 30, 2026