ArchSinus Stent System

Primary DI
07290019367000
Brand
ArchSinus Stent System
Company
STS Medical Ltd.
Model
712-001
Device description
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
Published
2022-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170913000Composite Removable Sinus Stent SystemSts Medical2017-12-15LYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019367000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019367000072900193670007290019367000

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Length18Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+972526826962lena@ststent.com

Regulatory Flags#

DUNS number
600613055
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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