FDA.reportPublic FDA data

Smoke Filter

Primary DI
05051223004110
Brand
Smoke Filter
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS3604
Catalog number
PS3604
Device description
The Smoke Filter enables simple, safe and effective removal of this surgical smoke during laparoscopic surgical procedures
Published
2016-09-17
Public version status
Update
Distribution status
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35051223004111PackageGS125In Commercial Distribution
05051223004110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505122300411135051223004111
05051223004110050512230041105051223004110

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.

Regulatory Flags#

DUNS number
239403863
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051223004684Ultimate Monopolar Straight Grasping Forceps with Ratchet PS3556ULTPS3556ULT2016-09-17
05051223004813Ultimate Monopolar Metzenbaum Scissor PS3551ULTPS3551ULT2016-09-17
05051223004820Ultimate Monopolar Maryland Dissecting Forceps PS3552ULTPS3552ULT2016-09-17
05051223004837Ultimate Monopolar Straight Grasping Forceps PS3553ULTPS3553ULT2016-09-17
05051223004844Ultimate Monopolar LapClinch with Ratchet PS3554ULTPS3554ULT2016-09-17
05051223005360Ultimate Monopolar scissorsPS3531ULTPS3531ULT2016-09-17
05051223005377Ultimate Maryland dissecting forcepsPS3532ULTPS3532ULT2016-09-17
05051223005384Ultimate Straight grasping forcepsPS3533ULTPS3533ULT2016-09-17
05051223005391Ultimate Lapclinch with ratchetPS3534ULTPS3534ULT2016-09-17
05051223005407Ultimate Straight grasping forceps with ratchetPS3536ULTPS3536ULT2016-09-17
05051223005414Ultimate Intestinal forceps with ratchet PS3537ULTPS3537ULT2016-09-17
05051223005421Ultimate Rat Tooth lapclinch with ratchetPS3538ULTPS3538ULT2016-09-17
05051223005438Ultimate BabcockPS3539ULTPS3539ULT2016-09-17
05051223005445Ultimate Monopolar Scissor PS3541ULTPS3541ULT2016-09-17
05051223005452Ultimate Maryland Dissecting Forceps PS3542ULTPS3542ULT2016-09-17
05051223005469Ultimate Straight Grasping Forceps PS3543ULTPS3543ULT2016-09-17
05051223005476Ultimate LapClinch with Ratchet PS3544ULTPS3544ULT2016-09-17
05051223005483Ultimate Straight Grasping Forceps with Ratchet PS3546ULTPS3546ULT2016-09-17
05051223005490Ultimate Intestinal Forceps with Ratchet PS3547ULTPS3547ULT2016-09-17
05051223005506Ultimate Rat Tooth LapClinch with Ratchet PS3548ULTPS3548ULT2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03