FDA.reportPublic FDA data

VisionAir 3D Stent

Primary DI
00811813020525
Brand
VisionAir 3D Stent
Company
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Model
0010-0126
Device description
Patient-Specific Silicone Airway Stent
Published
2024-03-11
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811813020525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

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
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2168005905info@visionairsolutions.com

Regulatory Flags#

DUNS number
078667390
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811813020006Glenoid IRI HandleM0006-00012016-09-02
00811813020013Glenoid IRI BarrelM0006-00022016-09-02
00811813020020Glenoid IRIS Surgical TrayE0006-00112016-09-02
00811813020037Glenoid IRI CapJ0006-00032016-09-02
00811813020044Glenoid IRI Leg (10mm)L0006-0005-102016-09-02
00811813020051Glenoid IRI Leg (11mm)L0006-0005-112016-09-02
00811813020068Glenoid IRI Leg (12mm)L0006-0005-122016-09-02
00811813020075Glenoid IRI Leg (13mm)L0006-0005-132016-09-02
00811813020082Glenoid IRI Leg (14mm)L0006-0005-142016-09-02
00811813020099Glenoid IRI Leg (15mm)L0006-0005-152016-09-02
00811813020105Glenoid IRI Leg (16mm)L0006-0005-162016-09-02
00811813020112Glenoid IRI Leg (17mm)L0006-0005-172016-09-02
00811813020129Glenoid IRI Leg (18mm)L0006-0005-182016-09-02
00811813020136Glenoid IRI Leg (19mm)L0006-0005-192016-09-02
00811813020143Glenoid IRI Leg (20mm)L0006-0005-202016-09-02
00811813020150Glenoid IRI Leg (21mm)L0006-0005-212016-09-02
00811813020167Glenoid IRI Leg (22mm)L0006-0005-222016-09-02
00811813020174Glenoid IRI Leg (23mm)L0006-0005-232016-09-02
00811813020181Glenoid IRI Leg (24mm)L0006-0005-242016-09-02
00811813020198Glenoid IRI Leg (25 mm)L0006-0005-252016-09-02

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Primary DI, Brand, Company table
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