VisionAir 3D Stent

GUDID 00811813020525

Patient-Specific Silicone Airway Stent

CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable

• Primary Device ID: 00811813020525
• NIH Device Record Key: 3124b1a1-007f-4260-b90d-fe908b0f9dc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisionAir 3D Stent
• Version Model Number: 0010-0126
• Company DUNS: 078667390
• Company Name: CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com
• Phone: 2168005905
• Email: info@visionairsolutions.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811813020525 [Primary]

FDA Product Code

• NWA: Prosthesis, Tracheal, Preformed/Molded

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

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• 00811813020525 - VisionAir 3D Stent: 2024-03-19 Patient-Specific Silicone Airway Stent
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• 00811813020006 - Glenoid IRI Handle: 2018-10-08 The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assem
• 00811813020013 - Glenoid IRI Barrel: 2018-10-08 The Glenoid IRI Barrel is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly i
• 00811813020037 - Glenoid IRI Cap: 2018-10-08 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