mcompass Anorectal Manometry System

GUDID 10851607003393

mcompass Anorectal Manometry System

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system
Primary Device ID10851607003393
NIH Device Record Keybfd9af03-f46c-4054-a9af-df64fc622316
Commercial Distribution StatusIn Commercial Distribution
Brand Namemcompass Anorectal Manometry System
Version Model NumberRMD-001U
Company DUNS962187964
Company NameMEDSPIRA, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003396 [Primary]
GS110851607003393 [Package]
Contains: 00851607003396
Package: Shipper [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-06

On-Brand Devices [mcompass Anorectal Manometry System]

10851607003058Medspira mcompass Diagnostic Anorectal Manometry system
10851607003393mcompass Anorectal Manometry System
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.