Identity
- Trade Name
- OSSEOUS Thermoplastic Splint Kit FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Device Name
- External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure. FDA UDI
- Model / Reference
- E5150K FDA UDI
- Description
- External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08906039316506 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
OSSEOUS Thermoplastic Splint Kit by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External nasal splint.
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- DENVER SPLINT — Summit Medical, LLC · Class I
- BRIDGEMASTER™ — MEDTRONIC XOMED, INC. · Class I
- Aquaplast PS™ — Qfix · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- Equipment box for external nasal splints — Spiggle & Theis Medizintechnik GmbH · 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
- Eon Meditech Private Limited
Sources (1)
- FDA UDI 0e104065-e904-4339-abd5-e44231fed2a6 34 fields · synced May 31, 2026