Home GUDID 00860009975156 Endocraft LLC
Primary DI 00860009975156
Brand Endocraft LLC
Company Endocraft, LLC
Model ZIN-100A
Catalog number ZIN-100A
Device description Zeitels Vocal Fold Infusion Needles are designed for vocal surgery for injection of needed fluid to surgical site.
Published 2023-07-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name KAA Set, Laryngeal Injection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KAA Set, Laryngeal Injection Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009975156 Primary GS1 0 00860009975163 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860009975156 00860009975156 860009975156 0860009975156 00860009975163 00860009975163 860009975163 0860009975163
GMDN Terms# Term, Definition table Term Definition Laryngeal injection kit A collection of surgical instruments, pharmaceuticals, and other items (e.g., dressings) intended to be used to perform an injection in the region of the larynx. This is a reusable device.
Sterilization Methods# Method table Method "[""Ethylene Oxide"", ""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]" Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 039432148 Device count 5 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# 
endocraft-llc.com