FDA.reportPublic FDA data

Surgimedics®

Primary DI
00814716020067
Brand
Surgimedics®
Company
COASTAL LIFE TECHNOLOGIES, INC.
Model
906760
Device description
Smoke Evacuator
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00814716020067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814716020067008147160200678147160200670814716020067

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809254670
Device count
1
Serial number
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

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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
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10193489085358MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
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20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
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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