Identity
- Trade Name
- DENVER SPLINT FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Model / Reference
- 10-4021-05KP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640048972 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
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 — FDA UDI — listed in FDA GUDID — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (1)
- FDA UDI d302c23e-0aaf-4e21-93d0-3489ffb09cd6 32 fields · synced May 30, 2026