AccessGUDID - DEVICE: GIOTTO IMAGE 3DL (08033837190035)

GUDID

Device Identifier (DI) Information

Brand Name: GIOTTO IMAGE 3DL
Version or Model: MAW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6006-15GM3
Company Name: I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL

Primary DI Number: 08033837190035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429113525 *Terms of Use

Device Description: MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.

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):	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?
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUE	Full Field Digital,System,X-Ray,Mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111434	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
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 1920 Millimeter
Depth: 470 Millimeter
Width: 1175 Millimeter

Device Record Status

Public Device Record Key: 9426ebb4-ffe9-4f58-b7fe-4d6507156155
Public Version Date: December 04, 2023
Public Version Number: 6
DI Record Publish Date: September 22, 2016