FDA.report

Laser Sensor

Primary DI
00817688021735
Brand
Laser Sensor
Company
I.C. MEDICAL, INC.
Model
ICM-000-0018
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K902611000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K902611000I.C. MEDICAL SMOKE EVACUATOR ACTIVATORI.C Medical, Inc.1990-08-17FYD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817688021735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817688021735008176880217358176880217350817688021735

GMDN Terms

TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Sterilization Methods

Method

Regulatory Flags

DUNS number
616182895
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00817688022947Speculum TubingICM-000-0600ICM-000-06002020-11-04
00817688022961Smoke Evacuator WandICM-000-0602ICM-000-06022020-11-04
00817688024293Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0714ICM-000-07142023-10-17
00817688024316Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0716ICM-000-07162023-10-17
00817688024330Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0718ICM-000-07182023-10-17
00817688024163PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0702ICM-000-07022023-10-12
00817688024194PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0704ICM-000-07042023-10-12
00817688024217PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0706ICM-000-07062023-10-12
00817688024231Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0708ICM-000-07082023-10-12
00817688024255Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0710ICM-000-07102023-10-12
00817688024279Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0712ICM-000-07122023-10-12
00817688024156Non-Telescopic PenEvacICM-000-0700ICM-000-07002023-08-29
00817688023975PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0684ICM-000-06842023-08-17
00817688023999Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0686ICM-000-06862023-08-17
00817688024019PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0688ICM-000-06882023-08-17
00817688024033Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0690ICM-000-06902023-08-17
00817688024057PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0692ICM-000-06922023-08-17
00817688024071Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®ICM-000-0694ICM-000-06942023-08-17
00817688024095PenEvac1®, MaxReveal ™ Diamond Crystal®ICM-000-0696ICM-000-06962023-08-17

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