n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551063453
• Version / Model: 20200043
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9367a7f6-07d5-40c4-ba2d-76a25e2336e0

Device Description

C-Mount Lens, f = 38 mm

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: 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: ["Ethylene Oxide", "Peracetic Acid", "Liquid Chemical", "Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FET	Endoscopic video imaging system/component, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32287	Surgical camera lens	An optical element of a surgical camera designed to change the degree of convergence or divergence of transmitted light to enable modification of viewed images (e.g., magnification, wide angle). It is made of glass and is available in a variety of dimensions. This is a non-sterilizable, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551063453	GS1

Premarket Submissions

Submission Number	Supplement Number
K994090	000