FDA.reportPublic FDA data

Skytron

Primary DI
10841736100810
Brand
Skytron
Company
SKYTRON LLC
Model
SMOKE-E-VAC
Catalog number
SMOKE-E-VAC
Device description
Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924732000PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.1993-09-13FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736100810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173610081010841736100810

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

Contacts#

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

Regulatory Flags#

DUNS number
078375583
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736125271Skytron4-040-224-040-222026-05-01
10841736125257Sterling Washers291853329185332026-04-26
10841736124441SkytronSOFPADII1-021-03-22026-04-14
10841736124458SkytronSOFPADII1-021-03-32026-04-14
10841736124465SkytronSOFPADII1-021-03-42026-04-14
10841736124472SkytronSOFPADII1-021-06-22026-04-14
10841736124489SkytronSOFPADII1-021-06-32026-04-14
10841736124496SkytronSOFPADII1-021-06-42026-04-14
10841736124502SkytronSOFPADII1-021-07-22026-04-14
10841736124519SkytronSOFPADII1-021-07-32026-04-14
10841736124526SkytronSOFPADII1-021-07-42026-04-14
10841736124533SkytronSOFPADII1-021-08-22026-04-14
10841736124540SkytronSOFPADII1-021-08-32026-04-14
10841736124557SkytronSOFPADII1-021-08-42026-04-14
10841736124564SkytronSOFPADII1-021-11-22026-04-14
10841736124571SkytronSOFPADII1-021-11-32026-04-14
10841736124588SkytronSOFPADII1-021-11-42026-04-14
10841736124595SkytronSOFPADII1-021-12-22026-04-14
10841736124601SkytronSOFPADII1-021-12-32026-04-14
10841736124618SkytronSOFPADII1-021-12-42026-04-14

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