Home GUDID 07290019367000
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
Product Codes# Code, Name table Code Name LYA Splint, Intranasal Septal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LYA Splint, Intranasal Septal Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290019367000 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290019367000 07290019367000 7290019367000
GMDN Terms# Term, Definition table Term Definition Intranasal splint, non-biodegradable A 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 Type Value Unit Stent Length 18 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide
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 Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10850056665305 ORCA Foam Orca Products, LLC LYA 2026-05-07 16975560670042 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670059 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670066 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670073 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670080 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670097 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670103 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670110 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670257 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670264 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670271 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670288 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670295 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 16975560670301 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 06975560670045 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 06975560670052 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 06975560670069 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 06975560670076 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 06975560670083 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 06975560670090 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 26975560670100 Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. LYA 2026-03-20 04250381820537 Expanding sinus tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250381820544 Expanding sinus tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250676730008 MENTIO disposable ear specula Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250676731104 Expanding nasal tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250676731111 Expanding nasal tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250676731128 Expanding nasal tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250676731135 Expanding nasal tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07 04250676741691 Expanding nasal tampon Spiggle & Theis Medizintechnik GmbH LYA 2025-10-07