Sterile cannula

Basic Information

• Brand Name: Sterile cannula
• Primary DI: 07290114063333
• Version / Model: Sterile cannula
• Catalog Number: STR-S00021-00
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Labeler DUNS: 531856466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-16
• Public Version: 1
• Public Version Date: 2023-05-24
• Public Version Status: New
• Public Device Record Key: 28f1b8dd-0852-4e86-8172-06a9352bc7bd

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 Unsafe
• 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
GZL	Electrode, Depth	Neurology	882.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61964	Intracerebral cannula, implantable	A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290114063330	GS1	Carton	10	In Commercial Distribution
Primary	07290114063333	GS1

Premarket Submissions

Submission Number	Supplement Number
K120098	000