Y-Stent with Tracheal Posts with 1mm Wall Thickness

GUDID 00815347020099

E. Benson Hood Laboratories Y-Stent

HOOD, E BENSON LABORATORIES INC

Tracheostomy tube, non-reinforced, non-customized, single-use

• Primary Device ID: 00815347020099
• NIH Device Record Key: 985d36e8-5e4b-4bea-858c-e0a5109e744a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-Stent with Tracheal Posts with 1mm Wall Thickness
• Version Model Number: YS1-1814-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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815347020099 [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

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00815347020099]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-29
• Device Publish Date: 2023-11-21

On-Brand Devices [Y-Stent with Tracheal Posts with 1mm Wall Thickness]

• 00815347024035: E. Benson Hood Laboratories Y-Stent
• 00815347024028: E. Benson Hood Laboratories Y-Stent
• 00815347020099: E. Benson Hood Laboratories Y-Stent
• 00815347020082: E. Benson Hood Laboratories Y-Stent