FDA.reportPublic FDA data

GI Trolly Silver

Primary DI
08717775955788
Brand
GI Trolly Silver
Company
Medical Measurement Systems B.V.
Model
GI Trolly Silver
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717775955788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717775955788087177759557888717775955788

GMDN Terms#

Term, Definition table
TermDefinition
Gastroduodenal motility analysis systemAn assembly of devices designed to evaluate peristaltic motility in the stomach and/or small intestines (usually the duodenum) by measuring pressure on an intragastric catheter/probe at several points. It typically includes a monitor display, computer, software, pressure catheter/probe, and a pH electrode to measure the acidity of the stomach contents. The system is intended to evaluate several diseases of the stomach and small intestines including the prediction of gastric and/or duodenal ulcers.

Regulatory Flags#

DUNS number
416277333
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717775955009Solar GI HRAM H2O, 24p, Trolley systemG3-142016-09-23
08717775955023Solar GI LGI H20, Compact Pole systemG3-32016-09-23
08717775955030Solar GI UGI H20, Trolley systemG3-52016-09-23
08717775955047Solar GI LGI H20, Trolley systemG3-62016-09-23
08717775955054Solar GI HRM H20, 24p, Compact Pole systemG3-72016-09-23
08717775955061Solar GI HRM H20, 24p, Trolley systemG3-82016-09-23
08717775955078Solar GI HRM H2O, 36p, Trolley systemG3-122016-09-23
08717775955085Solar GI HRAM H2O, 24p, Trolley systemG3-142016-09-23
08717775955092Solar GI HRM Solid State, Trolley systemG3-92016-09-23
08717775955108Solar GI HRIM Solid State, Trolley systemG3-102016-09-23
08717775955115Solar GI HRAM Solid State, Trolley systemG3-152016-09-23
08720648846007Solar GI air-charged 4P, Compact Pole systemG3-7 Air2022-05-07
08717775953050Impedance/pH, 6 imp channels, 1 pH antimony, Pediatric, 6.4 FrMMS-Z1-P-7R2016-09-23
08717775953098Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacingMMS-Z1-I2016-09-23
08717775953012Impedance/pH, 6 imp channels, 1 pH antimony, Adult, 6.4 FrMMS-Z1-A2016-09-23
08717775953036Impedance/pH, 6 imp channels, 2 pH antimony, Gastric+oes pH, AdultMMS-Z2G-A2016-09-23
08717775954071Impedance/pH, 6 imp channels, 1 pH antimony, LES locatorMMS-Z1-A-LES2016-09-23
08717775954095Impedance/pH,6 imp channels,2 pH antimony,acid LPR + oes,LES locatorMMS-Z2L-A-LES2016-09-23
08717775955016Ohmega RG2-12016-09-23
18717775956614MPP-PlusMPP-MT2025-02-21

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