Autoguide

Basic Information

• Brand Name: Autoguide
• Primary DI: 00763000573720
• Version / Model: 9736381
• Company Name: MEDTRONIC NAVIGATION, INC.
• Labeler DUNS: 835233107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-02
• Public Version: 1
• Public Version Date: 2022-04-11
• Public Version Status: New
• Public Device Record Key: 055c98be-9a46-4ee3-806c-05fe3bafdb22

Device Description

REDUCING TUBE 9736381 2.5MM SEEG

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: Yes
• 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
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38563	Brain biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable brain biopsy needle and other supplies used to perform a stereotaxic sampling of brain tissue. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000573720	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191597	000