NeoNavia Biopsy System

Basic Information

• Brand Name: NeoNavia Biopsy System
• Primary DI: 17350081940079
• Version / Model: 2104
• Catalog Number: 2104
• Company Name: NeoDynamics AB (publ)
• Labeler DUNS: 352793873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-20
• Public Version: 1
• Public Version Date: 2023-03-28
• Public Version Status: New
• Public Device Record Key: 01f69ba9-9ae2-49a2-baf7-7da85a3d0ad5

Device Description

NeoNavia FlexiPulse probe

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
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64327	End-cut biopsy gun needle	An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27350081940076	GS1	White inner box	5	In Commercial Distribution
Primary	17350081940079	GS1
Package	37350081940073	GS1	Cardboard box	2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K220595	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	14	Gauge

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 60 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity