AprioCore plus

Basic Information

• Brand Name: AprioCore plus
• Primary DI: 07350031350104
• Version / Model: ACP18-195-20
• Catalog Number: ACP18-195-20
• Company Name: Apriomed AB
• Labeler DUNS: 631734758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-23
• Public Version: 1
• Public Version Date: 2020-03-31
• Public Version Status: New
• Public Device Record Key: a805ad19-fb57-49a4-b2ce-a71e52528de4

Device Description

AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.

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: 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
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58990	Side-notch biopsy gun handpiece/needle	A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17350031350101	GS1	Shelf box	5	In Commercial Distribution
Primary	07350031350104	GS1
Package	27350031350108	GS1	Transportation box	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193268	000

Device Sizes

Type	Value	Unit	Text
Length	19.5	Centimeter
Needle Gauge	18	Gauge