AccessGUDID - DEVICE: SMART FINDER (08056977360113)

GUDID

Device Identifier (DI) Information

Brand Name: SMART FINDER
Version or Model: 28000-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMS GIOTTO SPA

Primary DI Number: 08056977360113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 437701793 *Terms of Use

Device Description: The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspiration, needle biopsy and guide wire placement.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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
IZH	System, X-Ray, Mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203509	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8019d08-cacb-499f-b451-d945c210f1a3
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 25, 2023