FDA.reportPublic FDA data

GoldVac Slim

Primary DI
20815198012391
Brand
GoldVac Slim
Company
Buffalo Filter
Model
15ft
Catalog number
60-7670-001
Device description
Push Button Smoke Evacuation Pencil, 15ft
Published
2019-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103375000PLUMEPEN INTEGRATED SMOKE EVACUATION PENCILMedtek Devices, Inc.2011-03-16GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815198012394PackageGS15In Commercial Distribution
20815198012391PackageGS14In Commercial Distribution
00815198012397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081519801239410815198012394
2081519801239120815198012391
00815198012397008151980123978151980123970815198012397

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787855907
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815198011031Buffalo FilterVT106102016-10-05
00815198011055Buffalo FilterVTWT4062016-09-30
00815198011086Buffalo FilterVT104052016-09-30
00815198011284Buffalo FilterVTWT2062016-09-30
00815198012519PenAdaptPA2010BCB2016-09-23
00815198012663Buffalo Filter777-007A2016-10-05
00815198012717InvuityPB1SEPB1SE2018-07-12
00815198012762OR-VACSEOOLLAP122018-07-12
00815198012779OR-VACOL3MT24OL3MT242018-07-12
00851136002068Buffalo FilterVTWT6242016-09-30
00851136002105Buffalo FilterVTWT4242016-09-30
00851136002143PenAdaptPA20102016-09-23
00851136002150Buffalo FilterVT103242016-10-05
00851136002174Buffalo FilterVT104242016-09-30
00851136002228PenAdaptPA2010CB2016-09-23
00851136002235Buffalo FilterVTVIC102016-09-30
00851136002266Buffalo FilterVT106242016-09-30
00851136002334Buffalo FilterPSFTS05PSFTS052017-01-06
00851136002358Buffalo FilterRF102102016-09-30
00851136002372PenAdaptPA1025CBPA1025CB2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02