Smoke Evacuator Wand

GUDID 00817688021605

I.C. MEDICAL, INC.

Surgical plume evacuation system tube
Primary Device ID00817688021605
NIH Device Record Key7f1a1848-54c7-46f0-bc1e-7057d8e8a2a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmoke Evacuator Wand
Version Model NumberICM-000-0030
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
GS100817688021599 [Primary]
GS100817688021605 [Package]
Contains: 00817688021599
Package: [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


[00817688021605]

Ethylene Oxide


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 [Smoke Evacuator Wand]

00817688021629ICM-000-0075
00817688021605ICM-000-0030
00817688022961Smoke Evacuator Wand, Universal Connector, Sterile

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