AccessGUDID - DEVICE: NeoNavia Biopsy System (17350081940086)

GUDID

Device Identifier (DI) Information

Brand Name: NeoNavia Biopsy System
Version or Model: 1102
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1102
Company Name: NeoDynamics AB (publ)

Primary DI Number: 17350081940086
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 base unit

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:	No
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?
36190	Mammographic stereotactic biopsy system	An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 53d9df3a-630e-4e08-8af7-a42712f812b1
Public Version Date: December 09, 2024
Public Version Number: 2
DI Record Publish Date: March 20, 2023