Endocraft LLC ZIN-100A

GUDID 00860009975156

Zeitels Vocal Fold Infusion Needles are designed for vocal surgery for injection of needed fluid to surgical site.

Endocraft, LLC

Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit Laryngeal injection kit

• Primary Device ID: 00860009975156
• NIH Device Record Key: 5adaba78-9aa0-4c84-929c-71276ab74736
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endocraft LLC
• Version Model Number: ZIN-100A
• Catalog Number: ZIN-100A
• Company DUNS: 039432148
• Company Name: Endocraft, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com
• Phone: 401-369-7344
• Email: info@endocraft-llc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009975156 [Primary]
GS1	00860009975163 [Unit of Use]

FDA Product Code

• KAA: Set, Laryngeal Injection

Sterilization

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

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00860009975156]

Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [Endocraft LLC]

• 00860009975156: Zeitels Vocal Fold Infusion Needles are designed for vocal surgery for injection of needed fluid
• 00860009975149: Zeitels Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This
• 00860009975132: Zeitels Suspension Gallows positions and holds the laryngoscope and patient in ideal posture for
• 00860009975125: Zeitels Intubation Scope. Slotted speculum to pass tube through trachea with Fiber optic carrier
• 00860009975118: European Angled Horizontal Handle Assembly for use with Storz-stlye scopes to connect to Suspens
• 00860009975101: Zeitels Slim Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery.
• 00860009975194: Fiberoptic Light Cable for surgical use.
• 00860009975187: Fiber optic light carrier for surgical illumination through endoscope. Connects to Light cable.
• 00860009975170: Single Lumen Suction Cannula for use in laser surgery to evacuate smoke plume.