Disposable Biopsy Needle

Basic Information

• Brand Name: Disposable Biopsy Needle
• Primary DI: 04048223028643
• Version / Model: 41778B
• Catalog Number: 41778B
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 5
• Public Version Date: 2025-12-01
• Public Version Status: Update
• Public Device Record Key: 6e4c7e0d-35e7-471d-a5a0-815062cda257
• Distribution End Date: 2025-03-15

Device Description

Disposable Biopsy Needle with Marker Plates; For Re-Order: 41779B (5 pcs of 41778B)

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Package	14048223028657	GS1	Box	5	Not in Commercial Distribution	2025-03-15
Primary	04048223028643	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060808	000