Endocraft LLC

Basic Information

• Brand Name: Endocraft LLC
• Primary DI: 00860009975125
• Version / Model: IS77
• Catalog Number: IS77
• Company Name: Endocraft, LLC
• Labeler DUNS: 039432148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-07
• Public Version: 1
• Public Version Date: 2023-07-17
• Public Version Status: New
• Public Device Record Key: 4e56e7e9-f99a-4bde-8a56-51548174b7f7

Device Description

Zeitels Intubation Scope. Slotted speculum to pass tube through trachea with Fiber optic carrier. Modular handle.

Device Characteristics

• Single Use: No
• 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
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15076	Rigid intubation laryngoscope, reusable	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	No	Active
46830	Laryngoscope handle, reusable	The hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009975125	GS1

Customer Contacts

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