AccessGUDID - DEVICE: MAMMI (08437018413041)

GUDID

Device Identifier (DI) Information

Brand Name: MAMMI
Version or Model: MAMMI DR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP-0203
Company Name: GENERAL EQUIPMENT FOR MEDICAL IMAGING SA

Primary DI Number: 08437018413041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 463337670 *Terms of Use

Device Description: MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring detector and a prone examination bed. - Breast PET Mammography System with a double ring detector and a prone examination bed (this record).

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:	Yes
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?
40644	PET system	An assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three-dimensional (3-D) tomographic digital cross-sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. It typically uses lead collimators and specialized software for image reconstruction allowing mapping of metabolic patterns and rates associated with targeted physiological processes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161631	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 -15 and 50 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Height: 1480 Millimeter
Length: 1430 Micrometer
Width: 661 Millimeter
Weight: 160 Kilogram

Device Record Status

Public Device Record Key: 2b107f0e-3257-4d36-8495-bab49efb6741
Public Version Date: January 24, 2022
Public Version Number: 1
DI Record Publish Date: January 14, 2022