Trachael Stent with Rings

GUDID 00815347022062

Hood Tracheo-bronchial prosthesis

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use

• Primary Device ID: 00815347022062
• NIH Device Record Key: aad63b3c-8d81-4c91-b219-da4e359032fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trachael Stent with Rings
• Version Model Number: TS-1090-S
• 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: true
• Serial Number: false
• 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	00815347022062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873742

FDA Product Code

• NWA: Prosthesis, Tracheal, Preformed/Molded

Sterilization

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

[00815347022062]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347022062]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347022062]

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: 2015-12-21

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