Endocraft LLC

Basic Information

• Brand Name: Endocraft LLC
• Primary DI: 00860009975156
• Version / Model: ZIN-100A
• Catalog Number: ZIN-100A
• Company Name: Endocraft, LLC
• Labeler DUNS: 039432148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: 5adaba78-9aa0-4c84-929c-71276ab74736

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAA	Set, Laryngeal Injection	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33427	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009975156	GS1
Unit of Use	00860009975163	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]