Huang Inner Ear Shunt

GUDID 00815347023601

Gibson Endolymphatic Shunt

HOOD, E BENSON LABORATORIES INC

Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use

• Primary Device ID: 00815347023601
• NIH Device Record Key: 6f688e5b-05a6-4f53-a772-07f638e1ed91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huang Inner Ear Shunt
• Version Model Number: GS-2000
• Company DUNS: 076603380
• Company Name: HOOD, E BENSON LABORATORIES INC
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815347023601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K897049

FDA Product Code

• ESZ: Tube, Shunt, Endolymphatic

Sterilization

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

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023601]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-07

Devices Manufactured by HOOD, E BENSON LABORATORIES INC

• 00815347020082 - Y-Stent with Tracheal Posts with 1mm Wall Thickness: 2023-11-29 E. Benson Hood Laboratories Y-Stent
• 00815347020099 - Y-Stent with Tracheal Posts with 1mm Wall Thickness: 2023-11-29 E. Benson Hood Laboratories Y-Stent
• 00815347023762 - Radiopaque Bronchial Stent with Posts: 2023-11-29 Hood Tracheo-Bronchial Prosthesis
• 00815347023779 - Radiopaque Bronchial Stent with Posts: 2023-11-29 Hood Tracheo-Bronchial Prosthesis
• 00815347023786 - Radiopaque Bronchial Stent with Posts: 2023-11-29 Hood Tracheo-Bronchial Prosthesis
• 00815347023793 - Radiopaque Tracheal Stent with Posts: 2023-11-29 Hood Tracheo-Bronchial Prosthesis
• 00815347023809 - Radiopaque Tracheal Stent with Posts: 2023-11-29 Hood Tracheo-Bronchial Prosthesis
• 00815347023816 - Radiopaque Bronchial Stent with Posts: 2023-11-29 Hood Tracheo-Bronchial Prosthesis