FDA.reportPublic FDA data

SeeClear MAX Laparoscopic Smoke Evacuation System

Primary DI
00888937015683
Brand
SeeClear MAX Laparoscopic Smoke Evacuation System
Company
Coopersurgical, Inc.
Model
SC062500
Device description
SeeClear MAX Laparoscopic Smoke Evacuation System
Published
2022-11-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCZTube, Smoke Removal, Endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCZTube, Smoke Removal, EndoscopicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937015687PackageGS110Not in Commercial Distribution
00888937015683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701568720888937015687
00888937015683008889370156838889370156830888937015683

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system filterA screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).

Regulatory Flags#

DUNS number
801895244
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033663ONETRAC™C1001102026-07-09
00888937033670ONETRAC™C1001402026-07-09
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060768280576SESISSURGEASE INNOVATIONS LIMITEDFCZ2026-05-09
00850003294841GynexJOSNOE MEDICAL, INC.FCZ2024-11-08
00850003294834GynexJOSNOE MEDICAL, INC.FCZ2024-11-08
04714127863184blue endoUNIMAX MEDICAL SYSTEMS INC.FCZ2024-06-20
14714127863181blue endoUNIMAX MEDICAL SYSTEMS INC.FCZ2024-06-20
00840306828393Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828409Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828416Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828423Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828430Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306822780Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822797Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822803Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822810Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822827Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822841Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822858Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822759Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
00840306822766Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
GYNX80091GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80241GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80721GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81001GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81031GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX82001GynexGYNEX CORPORATIONFCZ2023-12-19