← Back to catalogue

ENT Sinus

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
ENT Sinus FDA UDI
Generic Name
Intranasal splint, biodegradable FDA UDI
Device Name
MEDIENT MIDDLE TURBINATE IMPLANT 4-PACK FDA UDI
Model / Reference
602-00210 FDA UDI
Description
MEDIENT MIDDLE TURBINATE IMPLANT 4-PACK FDA UDI

Identifiers

Catalog Number
602-00210 FDA UDI
Primary DI / UDI-DI
00817470009767 FDA UDI
510(k) Number
K130354 FDA UDI
FDA Product Code
LYA FDA UDI
GMDN Term
Intranasal splint, biodegradable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4780 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intranasal splint, biodegradable

ENT Sinus by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intranasal splint, biodegradable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI a961e15a-ba9b-4a78-a69a-4e981a5fe0cd 36 fields · synced Jun 6, 2026