n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551345139
• Version / Model: 40800111
• 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: 2018-08-21
• Public Version: 2
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: 9c5c4da4-0dc4-461a-9650-c21bfa899322

Device Description

Optical Navigated Frontal Sinus Probe

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
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35253	Paranasal sinus probe	A hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551345139	GS1

Premarket Submissions

Submission Number	Supplement Number
K122096	000