FDA.reportPublic FDA data

PlumePen

Primary DI
00815198012236
Brand
PlumePen
Company
Buffalo Filter
Model
Pro
Catalog number
PLPRO4500
Device description
Smoke Plume Electrosurgical Pencil, Non-stick blade
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10815198012233PackageGS12In Commercial Distribution
20815198012230PackageGS15In Commercial Distribution
30815198012237PackageGS14In Commercial Distribution
00815198012236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081519801223310815198012233
2081519801223020815198012230
3081519801223730815198012237
00815198012236008151980122368151980122360815198012236

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
Length15Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
716-835-7000bf.smoke.info@filtrationgroup.com

Regulatory Flags#

DUNS number
787855907
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
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B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13