n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551086025
• Version / Model: 27618
• Catalog Number: 27618
• 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: 5
• Public Version Date: 2024-10-21
• Public Version Status: Update
• Public Device Record Key: 7a3cb7f5-b01b-4d91-b07e-dbc40624adbf

Device Description

Insertion Mandrin

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
KNY	ACCESSORIES, CATHETER, G-U	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13839	Urological catheter stylet, transurethral	A sterile, metal wire or flexible rod, typically with a plastic knob at the proximal end, intended to be inserted into the lumen of a urological catheter or cannula (not included) to increase stiffness sufficiently to facilitate manipulation/introduction into the urethra or ureter (via the urethra); it is not intended to assist introduction of a percutaneous catheter. It is available in various lengths, diameters, and degrees of rigidity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551086025	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]