Eliachar Laryngeal Stent

GUDID 00815347023328

Eliachar Laryngeal Stent

HOOD, E BENSON LABORATORIES INC

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

• Primary Device ID: 00815347023328
• NIH Device Record Key: 35d5ceeb-a627-416a-b745-3b97d91c9ed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eliachar Laryngeal Stent
• Version Model Number: ELL-3000
• 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	00815347023328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884810

FDA Product Code

• FWN: Prosthesis, Larynx (Stents And Keels)

Sterilization

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

[00815347023328]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023328]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347023328]

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: 2016-04-22

On-Brand Devices [Eliachar Laryngeal Stent]

• 00815347023335: Eliachar Laryngeal Stent
• 00815347023328: Eliachar Laryngeal Stent