FDA.reportPublic FDA data

Surgimedics®

Primary DI
10814716020538
Brand
Surgimedics®
Company
COASTAL LIFE TECHNOLOGIES, INC.
Model
901054
Device description
Smoke Evacuation Filter, In-line
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10814716020538PackageGS110In Commercial Distribution
00814716020531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081471602053810814716020538
00814716020531008147160205318147160205310814716020531

GMDN Terms#

Term, Definition table
TermDefinition
Suction system filter, plume particulateA screening device installed within the suction tubing line of a suction system, or the suction tubing used with a central vacuum system, to extract 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 clogging of the suction or vacuum system. 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 and can be made of translucent plastic, allowing for inspection when in use. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809254670
Device count
1
DM exempt
false
Premarket exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814716020866NA905114-REL2016-09-23
00814716020012Surgimedics®9050212016-09-23
00814716020029Surgimedics®9050182016-09-23
00814716020036Surgimedics®9050192016-09-23
00814716020043Surgimedics®9050602016-09-23
00814716020364Surgimedics®9050122016-09-23
00814716020494Surgimedics®9050252016-09-23
00814716020500Surgimedics®9050262016-09-23
00814716020517Surgimedics®9010252016-09-23
00814716020548Surgimedics®9020342016-09-23
00814716020555Surgimedics®9020372016-09-23
00814716020562Surgimedics®9050462016-09-23
00814716020579Surgimedics®9050482016-09-23
00814716020586Surgimedics®9050512016-09-23
00814716020593Surgimedics®9050612016-09-23
00814716020609Surgimedics®9050622016-09-23
00814716020616Surgimedics®9050452016-09-23
00814716020623Surgimedics®9010152016-09-23
00814716020630Surgimedics®9050112016-09-23
00814716020647Surgimedics®9050802016-09-23

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