Smoke Tubing

GUDID 00817688021544

I.C. MEDICAL, INC.

Surgical plume evacuation system tube
Primary Device ID00817688021544
NIH Device Record Key829a5456-2359-4467-ab86-1b3e8e8793cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmoke Tubing
Version Model NumberICM-000-0236
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
GS100817688021537 [Primary]
GS100817688021544 [Package]
Contains: 00817688021537
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

Ethylene Oxide


[00817688021544]

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 Tubing]

00817688021957ICM-000-0269
00817688021810ICM-000-0274
00817688021582ICM-000-0347
00817688021544ICM-000-0236
00817688021520ICM-000-0098

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