VisionAir 3D Stent

Primary DI
00860011822608
Brand
VisionAir 3D Stent
Company
VisionAir Solutions, LLC
Model
1
Catalog number
0010-0126
Device description
The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWAProsthesis, Tracheal, Preformed/Molded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWAProsthesis, Tracheal, Preformed/MoldedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213969000VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions2022-10-07NWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811813020525PreviousGS10
00860011822608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811813020525008118130205258118130205250811813020525
00860011822608008600118226088600118226080860011822608

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric tracheal/bronchial stent, non-bioabsorbableA non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmonary transplantation. It is made entirely of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., semi-soft continuous tube, covered or non-covered mesh structure, straight or branched configuration) intended to conform to the endotracheal/endobronchial surface. It may be expandable in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2168005905info@visionairsolutions.com

Regulatory Flags#

DUNS number
081278969
Device count
1
DM exempt
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

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