STS Medical Ltd.

Address:37 Amal Street,Petach Tikva Tel Aviv,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Splint, Intranasal Septal (LYA) (1)

Premarket Exempt

Clear

ArchSinus Stent System - 07290019367000 Catalog Number :

Device Description : The Composite Removable Sinus Stent is intended for use in adult patients follow The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, tomaintain patency and reduce the need of post-operative intervention or revision surgery. The composite stent isintended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steadysupport of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction byadhesions. The stent can be removed at any time within 28 days by cooling and self-crimping

Device Class : 1

Duns Number: 600613055

Premarket Exempt : No

Product Code : LYA

Prescription Use : Yes

Device Count : 1

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