n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551051627
• Version / Model: 11573NP
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: 8eae3b6f-fe97-4a3c-954a-0d7ea8a8d4c4

Device Description

Stone Extractor, 10x

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58981	Salivary stone retrieval basket	A sterile, flexible, manual endotherapy instrument designed to remove salivary stones (calculi) from a salivary duct during an endoscopic procedure. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire at its distal end in which the stones are caught for extraction. It is typically introduced through the working channel of a sialendoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551051627	GS1
Unit of Use	04048551261910	GS1

Premarket Submissions

Submission Number	Supplement Number
K012527	000