ENDOMAT

Basic Information

• Brand Name: ENDOMAT
• Primary DI: 04048551066423
• Version / Model: 20330320-1
• 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: 04af9dec-1e35-4c1a-b8fb-3410aace79df

Device Description

ENDOMAT® LC SCB, Roller Pump

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	endoscopic irrigation/suction system	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10217	Surgical suction system	An assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551066423	GS1

Premarket Submissions

Submission Number	Supplement Number
K031457	000