AccessGUDID - DEVICE: GIOTTO IMAGE (08033837190103)

GUDID

Device Identifier (DI) Information

Brand Name: GIOTTO IMAGE
Version or Model: GIOTTO IMAGE M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6501
Company Name: I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL

Primary DI Number: 08033837190103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429113525 *Terms of Use

Device Description: Giotto Image is a conventional film-screen x-ray mammographic device.

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?
37672	Stationary mammographic x-ray system, digital	A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZH	System, X-Ray, Mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012953	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 Atmospheric Pressure: between 700 and 1060 KiloPascal
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 2240 Millimeter
Depth: 1140 Millimeter
Width: 1150 Millimeter

Device Record Status

Public Device Record Key: 14b1c6ed-51c6-443d-86ee-3e609e1bd03f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016