n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551425824
• Version / Model: 11304BCX
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-11
• Public Version: 1
• Public Version Date: 2020-01-20
• Public Version Status: New
• Public Device Record Key: fe65ab0f-d9cd-4276-8446-73c02deec193

Device Description

Flex. Intubation Video Endoscope 6.5x65

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Peracetic Acid", "Ethylene Oxide", "Hydrogen Peroxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAL	LARYNGOSCOPE, NON-RIGID	Anesthesiology	868.5530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44962	Flexible video intubation laryngoscope, reusable	An endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551425824	GS1