n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551251669
• Version / Model: 8997E
• 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: 2d0840cc-b6bc-450c-9da3-6feaa45147dd

Device Description

Endoscope Holder

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCV	Endoscope holder	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38724	Neurological endoscope holder	A device intended to be used to hold and fix in position a rigid or flexible endoscope during a diagnostic or therapeutic neurological procedure. It is typically made of high-grade stainless steel and anodized aluminium and will usually be affixed to the operating/examination table enabling the surgeon to freely use both hands. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551251669	GS1

Premarket Submissions

Submission Number	Supplement Number
K990334	000