VisionAir 3D Stent

GUDID 00811813020525

Patient-Specific Silicone Airway Stent

CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Polymeric tracheal/bronchial stent, non-bioabsorbable
Primary Device ID00811813020525
NIH Device Record Key3124b1a1-007f-4260-b90d-fe908b0f9dc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisionAir 3D Stent
Version Model Number0010-0126
Company DUNS078667390
Company NameCUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com
Phone2168005905
Emailinfo@visionairsolutions.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100811813020525 [Primary]

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


[00811813020525]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

Devices Manufactured by CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

00811813020525 - VisionAir 3D Stent2024-03-19Patient-Specific Silicone Airway Stent
00811813020525 - VisionAir 3D Stent2024-03-19 Patient-Specific Silicone Airway Stent
00811813020020 - Glenoid IRIS Surgical Tray2019-08-09 The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that contains all of the Arthrex Glenoid IRI
00811813020235 - SmartBone2019-02-07 The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at
00811813020006 - Glenoid IRI Handle2018-10-08 The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assem
00811813020013 - Glenoid IRI Barrel2018-10-08 The Glenoid IRI Barrel is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly i
00811813020037 - Glenoid IRI Cap2018-10-08 The Glenoid IRI Cap is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly is i
00811813020044 - Glenoid IRI Leg (10mm)2018-10-08 The Glenoid IRI Leg (10mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (10mm) is i
00811813020051 - Glenoid IRI Leg (11mm)2018-10-08 The Glenoid IRI Leg (11mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (11mm) is i

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.