AccessGUDID - DEVICE: NeoNavia Biopsy System (17350081940079)

GUDID

Device Identifier (DI) Information

Brand Name: NeoNavia Biopsy System
Version or Model: 2104
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2104
Company Name: NeoDynamics AB (publ)

Primary DI Number: 17350081940079
Issuing Agency: GS1
Commercial Distribution End Date: October 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 352793873 *Terms of Use

Device Description: NeoNavia FlexiPulse probe

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 14 Gauge

Device Record Status

Public Device Record Key: 01f69ba9-9ae2-49a2-baf7-7da85a3d0ad5
Public Version Date: December 09, 2024
Public Version Number: 2
DI Record Publish Date: March 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
27350081940076	5	17350081940079	2024-10-14	Not in Commercial Distribution	White inner box
37350081940073	2	27350081940076	2024-10-14	Not in Commercial Distribution	Cardboard box