ULPA Box Filter

GUDID 00817688021681

I.C. MEDICAL, INC.

Surgical plume evacuation system
Primary Device ID00817688021681
NIH Device Record Key1a585855-1af9-43c1-82ab-2a67c06999d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameULPA Box Filter
Version Model NumberICM-000-0289
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688021674 [Primary]
GS100817688021681 [Package]
Contains: 00817688021674
Package: [10 Units]
In Commercial Distribution

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 [ULPA Box Filter]

00817688021780ICM-000-0460
00817688021681ICM-000-0289
00817688021667ICM-000-0276
00817688021643ICM-000-0262

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