AccessGUDID - DEVICE: GIOTTO IMAGE 3DL (08033837190011)

GUDID

Device Identifier (DI) Information

Brand Name: GIOTTO IMAGE 3DL
Version or Model: GIOTTO IMAGE_20'' 3Mpixel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6909
Company Name: I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL

Primary DI Number: 08033837190011
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 mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.

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?
36513	Mammographic x-ray system stereotactic unit	A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography.	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: 2240 Millimeter
Depth: 1140 Millimeter
Width: 1150 Millimeter

Device Record Status

Public Device Record Key: 5e154c88-f50c-4a1c-85ed-6b7cdd312449
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016