NA

Basic Information

• Brand Name: NA
• Primary DI: 20763000210216
• Version / Model: DB-5000
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-10-24
• Public Version: 1
• Public Version Date: 2021-11-01
• Public Version Status: New
• Public Device Record Key: bfa61527-c141-4729-9ca4-196b7cbbd779

Device Description

ACCY KIT DB-5000 STMLOC CLIP ASSEMBLY

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: No
• Has Expiration Date: No
• 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
32577	Neurosurgical headrest	A device designed to be attached to an appropriate operating table to support and immobilize the head of a recumbent patient during a neurosurgical procedure. The headrest is typically made of metal and synthetic materials that incorporate a semicircular cupped cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustment to facilitate surgeon access to the skull. This device may be attached to dedicated chairs used for neurosurgical procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00763000210212	GS1
Primary	20763000210216	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001096	000