Identity
- Trade Name
- SUMMIT MEDICAL FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Model / Reference
- 72-3021 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640064200 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
Summit Medical by Summit Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External nasal splint.
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- 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 |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (1)
- FDA UDI dd0b810e-bbf2-43b9-a3c2-e75ccdc5adf9 32 fields · synced Jun 8, 2026