FDA.reportPublic FDA data

NA

Primary DI
00814716020807
Brand
NA
Company
COASTAL LIFE TECHNOLOGIES, INC.
Model
6082K
Device description
Smoke Evacuation Filter
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814716020807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814716020807008147160208078147160208070814716020807

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809254670
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
10705036046523MegadyneETHICON ENDO-SURGERY, LLCFYD2026-05-27
10860012888808Flamingo Funnel (miniSQUAIR) - LargeNASCENT SURGICAL, LLCFYD2026-05-01
10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10193489085358MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
10845854600092Smoke Shark IIIConmed CorporationFYD2021-02-12
20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
40845854081830VIROSAFEConmed CorporationFYD2021-01-20
10845854082898BOVIE SharkSkinConmed CorporationFYD2021-01-07
40845854053127MEGADYNE MICROSAFEConmed CorporationFYD2020-12-08
10845854053096MINIVACConmed CorporationFYD2020-11-20
10845854053102MINIVACConmed CorporationFYD2020-11-20
20845854082802VIROSAFEConmed CorporationFYD2020-11-02
20845854081775OR-VACConmed CorporationFYD2020-10-23
20845854081058OR-VACConmed CorporationFYD2020-10-21
30845854081024OR-VACConmed CorporationFYD2020-10-21
30845854081031OR-VACConmed CorporationFYD2020-10-21
30845854081048OR-VACConmed CorporationFYD2020-10-21
30845854081680NAConmed CorporationFYD2020-10-14
20845854081706BOWAConmed CorporationFYD2020-09-30
20845854053192PENADAPTConmed CorporationFYD2020-09-17
20845854061814BOWAConmed CorporationFYD2020-09-15
20845854061821BOWAConmed CorporationFYD2020-09-15
20845854060015VIROSAFEConmed CorporationFYD2020-09-13
20845854081805HarmonyAIRConmed CorporationFYD2020-09-11
30845854053182BOWAConmed CorporationFYD2020-09-05
10614559104521MegadyneMEGADYNE MEDICAL PRODUCTS, INC.FYD2020-09-02