ArchSinus Stent System

GUDID 07290019367000

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

STS Medical Ltd.

Intranasal splint, non-biodegradable

• Primary Device ID: 07290019367000
• NIH Device Record Key: f7d474e8-6cc1-4557-b468-f1a00d1ae2c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArchSinus Stent System
• Version Model Number: 712-001
• Company DUNS: 600613055
• Company Name: STS Medical Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com
• Phone: +972526826962
• Email: lena@ststent.com

Device Dimensions

• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter
• Stent Length: 18 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019367000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170913

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

[07290019367000]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31