n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551052471
• Version / Model: 12016EF
• 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: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: a25157d3-f7d7-4673-ac23-170dd3d34568

Device Description

Esophagoscope Tube, size 11

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: No
• 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: ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

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
36653	Rigid optical oesophagoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551052471	GS1

Premarket Submissions

Submission Number	Supplement Number
K943667	000