Em Disposable Stylet

Basic Information

• Brand Name: Em Disposable Stylet
• Primary DI: 04056481006525
• Version / Model: 18097
• Catalog Number: 18097
• Company Name: Brainlab AG
• Labeler DUNS: 314482980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-08
• Public Version: 5
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: a6e923ec-9610-4f80-a5d9-435b09eafa30

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: Yes
• 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
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38723	Robotic surgical navigation system	An assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.	No	Active
63570	Intracranial catheter navigation transmitter stylet	A sterile, invasive, flexible wire with an electromagnetic (EM) coil transmitter at the distal end designed to be inserted into an intracranial catheter to help guide the surgical insertion of the catheter through the skull for placement in the brain. It is proximally connected to a line-powered EM neurosurgical navigation system which tracks and displays the position of the stylet for precise navigation during the procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04056481004958	GS1		10	In Commercial Distribution
Primary	04056481006525	GS1
Package	04056481004965	GS1		1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092467	000
K213989	000