Identity
- Trade Name
- BiValve Nasal Splint Thin FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- Internal Nasal Splints EUDAMED
- Model / Reference
- SP-27010 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SP-27010 FDA UDI
- Primary DI / UDI-DI
- 00385640000055 EUDAMEDFDA UDI
- Basic UDI-DI
- 03856410497_INTSPLINTSLP EUDAMED
- FDA Product Code
- EPP FDA UDI
- EMDN Code
- P020203 NASAL SPLINTS EUDAMED
- GMDN Term
- Intranasal splint, non-biodegradable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.5800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intranasal splint, non-biodegradable
BiValve Nasal Splint Thin by Summit Medical, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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- Custom Nasal Splint — Boston Medical Products, Inc. · 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
- Summit Medical, LLC
Sources (2)
- FDA UDI b3a27cb9-baa7-4e1c-b14a-15ecdc7b3327 34 fields · synced Jun 19, 2026
- EUDAMED efd5021a-ba4f-486d-a104-5215d12f9b6d 61 fields · synced Jun 19, 2026