Identity
- Trade Name
- The Denver Splint 4000 EUDAMEDDENVER SPLINT FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Device Name
- The Denver Splint (Non-Kit) EUDAMED
- Model / Reference
- 10-4021-10NKL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640048958 EUDAMEDFDA UDI
- Basic UDI-DI
- 03856492982_DENVERSPNKNL EUDAMED
- FDA Product Code
- EPP FDA UDI
- EMDN Code
- P020203 NASAL SPLINTS EUDAMED
- GMDN Term
- External nasal splint 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
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
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
Yes
FDA UDI
Category: External nasal splint
Denver Splint by Summit Medical, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External nasal splint.
- ENTPROMED — ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · Class I
- External aluminium nasal splint — Spiggle & Theis Medizintechnik GmbH · Class I
- BRIDGEMASTER™ — MEDTRONIC XOMED, INC. · Class I
- Aquaplast PS™ — Qfix · Class I
- Equipment box for external nasal splints — Spiggle & Theis Medizintechnik GmbH · Class I
- Internal nasal splint with airway — GENCO TIBBI CIHAZLAR SAN. TIC.LTD. STI. · Class IIa
- ENTPROMED — ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · Class I
- Thermoplastic Nasal Splints — Qfix · 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 011d456f-f1b2-4f1c-9934-7e8ba0d28264 32 fields · synced Jul 28, 2026
- EUDAMED 3730dfee-c100-4be0-9eb4-f06c87b507f9 61 fields · synced Jul 28, 2026