FDA.reportPublic FDA data

SOLAR Compact

Primary DI
08720648846052
Brand
SOLAR Compact
Company
Laborie Medical Technologies Corp.
Model
G4-1
Device description
SOLAR Compact
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08720648846052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720648846052087206488460528720648846052

GMDN Terms#

Term, Definition table
TermDefinition
Manometric gastrointestinal motility analysis systemAn assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117783313
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20627825008550TENS/EMS Electrode Procedure PackDIS70002026-05-19
10627825014844T-DOC 5Fr Air-Charged Abdominal Sensor CatheterCAT5752024-12-12
10627825014851T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595P2024-12-12
10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595S2024-12-12
00627825014830SOLAR Anorectal Manometry CatheterK1210AC-L-22122025-03-06
00627825014823SOLAR Anorectal Manometry ChargerZM12-AC59-22132025-03-06
10627825014837SOLAR Anorectal Manometry CatheterK1210AC-L-22122025-03-06
08720648846069PIM NXT for eSensePIX70002025-02-21
00627825013536e•Sense 7Fr Single Sensor Coudé Bladder CatheterCATEB27C2024-12-12
00627825013543e•Sense 7Fr Dual Sensor Urethral CatheterCATEB372024-12-12
00627825013529e•Sense 7Fr Single Sensor Bladder CatheterCATEB272024-12-12
10627825013533e•Sense 7Fr Single Sensor Coudé Bladder CatheterCATEB27C2024-12-12
10627825013540e•Sense 7Fr Dual Sensor Urethral CatheterCATEB372024-12-12
00627825013550e•Sense 7Fr Dual Sensor Coudé Uretheral CatheterCATEB37C2024-12-12
00627825013567e•Sense 7Fr Abdominal CatheterCATEA172024-12-12
20627825014841T-DOC 5Fr Air-Charged Abdominal Sensor CatheterCAT5752024-12-12
20627825014858T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595P2024-12-12
20627825014865T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595S2024-12-12
00627825014540Urostym EMG Stimulation Cable, Ch 1CAB8962022-11-10
00627825014557Urostym EMG Cable, Ch 2CAB9062022-11-10

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Primary DI, Brand, Company table
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00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
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00816734023457Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16