Identity
- Trade Name
- OSSEOUS Fluoroplastic Sheet FDA UDI
- Generic Name
- Silicone-sheet tissue reconstructive material FDA UDI
- Device Name
- Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure. FDA UDI
- Model / Reference
- E3146USF FDA UDI
- Description
- Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904461000086 FDA UDI
- FDA Product Code
- EPP FDA UDI
- GMDN Term
- Silicone-sheet tissue reconstructive material 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 0.25 Millimeter FDA UDI
Category: Silicone-sheet tissue reconstructive material
OSSEOUS Fluoroplastic Sheet by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-sheet tissue reconstructive material.
- Silicone Sheeting Open Border — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Reinforced — Bentec Medical OpCo, LLC. · Class II
- SILICONE SHEETING — Summit Medical, LLC · Class I
- Silicone Sheeting Open Border — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Reinforced — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Open Border — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC. · Class II
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 1dd480a6-89c7-4cb6-a66d-710b1249b9e0 35 fields · synced May 30, 2026