Radiopaque Laryngeal Umbrella Keel

GUDID 00815347023380

E. Benson Hood Laboratories Umbrella Keel

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use

• Primary Device ID: 00815347023380
• NIH Device Record Key: 09bf7e9f-1486-435f-beec-b118c7def238
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiopaque Laryngeal Umbrella Keel
• Version Model Number: RLK-14
• 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	00815347023380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841348

FDA Product Code

• FWN: Prosthesis, Larynx (Stents And Keels)

Sterilization

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

[00815347023380]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023380]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023380]

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: 2016-04-21

On-Brand Devices [Radiopaque Laryngeal Umbrella Keel]

• 00815347023397: E. Benson Hood Laboratories Umbrella Keel
• 00815347023380: E. Benson Hood Laboratories Umbrella Keel
• 00815347023373: E. Benson Hood Laboratories Umbrella Keel