ESU Sensor ICM-000-0422

GUDID 00817688021742

I.C. MEDICAL, INC.

Surgical plume evacuation system
Primary Device ID00817688021742
NIH Device Record Keye5733fc6-c678-4582-a38f-9cf7d4e4d655
Commercial Distribution StatusIn Commercial Distribution
Brand NameESU Sensor
Version Model Number2250
Catalog NumberICM-000-0422
Company DUNS616182895
Company NameI.C. MEDICAL, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688021742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-08
Device Publish Date2016-09-24

On-Brand Devices [ESU Sensor]

008176880217422250
00817688021711ICM-000-0009

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.