GUARDIAN™

Basic Information

• Brand Name: GUARDIAN™
• Primary DI: 05415067030283
• Version / Model: 6010
• Catalog Number: 6010
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-24
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: e04fffa2-eb84-4fb2-98d5-8cf3b5f6f4ac

Device Description

Cranial Burr Hole Cover Sys.

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: MR Conditional
• 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
GXR	COVER, BURR HOLE	Neurology	882.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46642	Craniofacial fixation plate, non-bioabsorbable, non-customized	A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067030283	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181382	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal