FDA.reportPublic FDA data

SkyVac

Primary DI
10841736100964
Brand
SkyVac
Company
SKYTRON LLC
Model
SVAC1
Catalog number
SVAC1
Device description
8 hour filter for Skytron Smoke Evacuation System Models SVAC-P/K Ergon 2
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10841736100964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173610096410841736100964

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).

Contacts#

Phone, Email table
PhoneEmail
+1(800)759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736117085Skytron1-011-01-211-011-01-212022-01-29
10841736117092Skytron1-011-01-221-011-01-222022-01-29
10841736117108Skytron1-011-01-31-011-01-32022-01-29
10841736117115Skytron1-011-01-41-011-01-42022-01-29
10841736117122Skytron1-011-01-51-011-01-52022-01-29
10841736117283Skytron1-011-02-421-011-02-422022-01-29
10841736117313Skytron1-011-02-521-011-02-522022-01-29
10841736117351Skytron1-011-03-51-011-03-52022-01-29
10841736117375Skytron1-011-04-221-011-04-222022-01-29
10841736117382Skytron1-011-04-231-011-04-232022-01-29
10841736117412Skytron1-011-04-431-011-04-432022-01-29
10841736117429Skytron1-011-04-51-011-04-52022-01-29
10841736117443Skytron1-011-05-211-011-05-212022-01-29
10841736117450Skytron1-011-05-221-011-05-222022-01-29
10841736117498Skytron1-011-05-51-011-05-52022-01-29
10841736117603Skytron1-011-06-311-011-06-312022-01-29
10841736117658Skytron1-011-06-3B1-011-06-3B2022-01-29
10841736117726Skytron1-011-06-421-011-06-422022-01-29
10841736117801Skytron1-011-07-211-011-07-212022-01-29
10841736117825Skytron1-011-07-41-011-07-42022-01-29

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Primary DI, Brand, Company table
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10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
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