FDA.reportPublic FDA data

Sun Medical Inc

Primary DI
B22691200000
Brand
Sun Medical Inc
Company
SUN MEDICAL INC
Model
SFE200
Catalog number
9120000
Device description
Smoke/Fluid evacuator system
Published
2017-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K911154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911154000SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200Sun Medical, Inc.1991-07-26FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B22691200000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/smoke waste management system suction unitA mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9033569000Spolk@sunmedicalinc.com

Regulatory Flags#

DUNS number
095223103
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B22687300000Sun Medical Inc873000087300002017-01-23
B22687300001Sun Medical Inc873000087300002017-01-23
B226841080Sun Medical Inc84108841082016-08-02
B226841082Sun Medical Inc84108841082017-01-23
B226841100Sun Medical Inc84110841102017-01-23
B226841102Sun Medical Inc84110841102017-01-23
B226841120Sun Medical Inc84112841122017-01-23
B226841122Sun Medical Inc841128411222017-01-23
B226841140Sun Medical Inc84114841142017-01-23
B226841142Sun Medical Inc84114841142017-01-23
B226842080Sun Medical Inc84208842082017-01-23
B226842082Sun Medical Inc84208842082017-01-23
B226842100Sun Medical Inc84210842102017-01-23
B226842102Sun Medical Inc84210842102017-01-23
B226842120Sun Medical Inc84212842122017-01-23
B226842122Sun Medical Inc84212842122017-01-23
B226842140Sun Medical Inc84214842142017-01-23
B226842142Sun Medical Inc84214842142017-01-23
B226843000Sun Medical INc84300843002017-01-23
B226843002Sun Medical Inc84300843002017-01-23

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