n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551417348
• Version / Model: 091370-06
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-03-02
• Public Version: 1
• Public Version Date: 2020-03-10
• Public Version Status: New
• Public Device Record Key: ec59242a-2c83-451c-b356-cc16aef64f68

Device Description

CMOS Video Esophagoscope SSU

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOX	Esophagoscope (flexible or rigid)	Ear, Nose, Throat	874.4710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63329	Flexible video oesophagoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04048551417355	GS1
Primary	04048551417348	GS1

Premarket Submissions

Submission Number	Supplement Number
K192523	000