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ENT Sinus

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
ENT Sinus FDA UDI
Generic Name
Intranasal splint, biodegradable FDA UDI
Device Name
ENTACT SEPTAL STAPLER 3 PACK FDA UDI
Model / Reference
601-00100 FDA UDI
Description
ENTACT SEPTAL STAPLER 3 PACK FDA UDI

Identifiers

Catalog Number
601-00100 FDA UDI
Primary DI / UDI-DI
00817470006452 FDA UDI
510(k) Number
K082750 FDA UDI
FDA Product Code
OLL FDA UDI
GMDN Term
Intranasal splint, biodegradable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intranasal splint, biodegradable.

Cleared under the same submission

K082750 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 654dded9-291b-417a-9b6c-9ab06be7534c 36 fields · synced Jun 8, 2026