2195J

GUDID 00817688022312

ICM-000-0418

I.C. MEDICAL, INC.

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Primary Device ID00817688022312
NIH Device Record Key4bf7b9c2-becf-4b96-ac02-a7877a4eea41
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2195J
Catalog Number2195J
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688021414 [Previous]
GS100817688022305 [Primary]
GS100817688022312 [Package]
Contains: 00817688022305
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-08
Device Publish Date2017-09-15

Devices Manufactured by I.C. MEDICAL, INC.

00817688022947 - Speculum Tubing2024-05-03 Speculum Tubing, 22mm to 10mm Connector, Sterile
00817688022961 - Smoke Evacuator Wand2024-05-03 Smoke Evacuator Wand, Universal Connector, Sterile
00817688024293 - Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®2023-10-25 Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, Universal Connec
00817688024316 - Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®2023-10-25 Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, 22mm to 10mm to
00817688024330 - Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®2023-10-25 Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, 10mm to Filter C
00817688024163 - PenEvac1®, MaxReveal ™ Diamond Crystal®2023-10-20 PenEvac1®-ST, MaxReveal ™ Diamond Crystal®, 70 mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holster, S
00817688024194 - PenEvac1®, MaxReveal ™ Diamond Crystal®2023-10-20 PenEvac1®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 22mm to 10mm Connector and Holster
00817688024217 - PenEvac1®, MaxReveal ™ Diamond Crystal®2023-10-20 PenEvac1®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 10mm to Filter Connector and Holst
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