MIP Minimal Invasive PCNL

Basic Information

• Brand Name: MIP Minimal Invasive PCNL
• Primary DI: 04048551366660
• Version / Model: 27840KA
• 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: 2019-02-23
• Public Version: 2
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: aa7a8d86-bfa0-4ec5-8f8a-444c0510096b

Device Description

Nephroscope for MIP L

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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGA	Kit, nephroscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15290	Rigid optical nephroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the internal structures of the kidney and may be used in the removal of renal calculi. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551366660	GS1

Premarket Submissions

Submission Number	Supplement Number
K940594	000