OSSEOUS Silicone Block

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS Silicone Block FDA UDI
Generic Name: Silicone-sheet tissue reconstructive material FDA UDI
Device Name: "Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. " FDA UDI
Model / Reference: E3146BS FDA UDI
Description: "Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. " FDA UDI

Identifiers

Primary DI / UDI-DI: 08906039310719 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 5 Centimeter FDA UDI
Width — 3 Centimeter FDA UDI
Height — 1 Centimeter FDA UDI

Category: Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Block 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 d9b3ee4f-9c96-4e66-bab7-b4b8d6549441 35 fields · synced May 30, 2026