Disposable Brain Biopsy Needle Kit

Basic Information

• Brand Name: Disposable Brain Biopsy Needle Kit
• Primary DI: 00841823100962
• Version / Model: DBN-10-19X
• Catalog Number: DBN-10-19X
• Company Name: Ad-Tech Medical Instrument Corporation
• Labeler DUNS: 174813410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: 63c47b15-0655-4551-80b6-ce125d38d674

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: 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
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	00841823100962	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K924348	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: To be stored and used within typical hospital/office room ambient temperature and humidity conditions