mcompass Anorectal Manometry System RMD-001

GUDID 10851607003058

Medspira mcompass Diagnostic Anorectal Manometry system

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system
Primary Device ID10851607003058
NIH Device Record Key0cd4a39c-a42f-4f29-9fad-1d23290216db
Commercial Distribution StatusIn Commercial Distribution
Brand Namemcompass Anorectal Manometry System
Version Model NumberRMD-001
Catalog NumberRMD-001
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 Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003051 [Primary]
GS110851607003058 [Package]
Contains: 00851607003051
Package: Shipper [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLAMonitor, Esophageal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-01-06

On-Brand Devices [mcompass Anorectal Manometry System]

10851607003058Medspira mcompass Diagnostic Anorectal Manometry system
10851607003393mcompass Anorectal Manometry System

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