FDA.reportPublic FDA data

MediMax Tech

Primary DI
00817325023634
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
SPDE-SL5
Device description
SPDE-SL-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Non-Stick Blade, 5 Meter hose
Published
2019-12-02
Public version status
Update
Distribution status
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
K092732000
K143103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092732000PROPENCIL ESU PENCILBio Protech, Inc.2009-11-25GEI
K143103000PROPENCIL Smoke PencilBio Protech, Inc.2015-07-16GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817325023631PackageGS110In Commercial Distribution
20817325023638PackageGS14In Commercial Distribution
00817325023634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502363110817325023631
2081732502363820817325023638
00817325023634008173250236348173250236340817325023634

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
855-633-4629support@medimaxtech.com

Regulatory Flags#

DUNS number
927071162
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817325025003iVisionOCV-20-S12026-04-30
00817325025010iChopperIC-27G2026-04-30
00817325023764MediMax TechPSF22020-09-24
00817325023771MediMax TechASF32020-09-24
00817325023788MediMax TechASFN32020-09-24
00817325023795MediMax TechASFT032020-09-24
00817325023801MediMax TechTS32020-11-16
00817325023818MediMax TechTV32020-11-16
00817325023825MediMax TechTO3 2020-11-16
00817325026574MediMaxTech Inc.MSH22M2024-03-25
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
00817325020381MediMax TechNCS-SG15 Surface Electrodes2016-08-19
00817325020398MediMax TechMF2409 Surface Electrodes2016-08-19
00817325020350MediMax TechSG15R Surface Electrodes2016-08-19
00817325020367MediMax TechSG15G Surface Electrodes2016-08-19
00817325022729MediMax TechSG15G Surface Electrodes- 5 pc Sample Pack2017-01-18
00817325020695MediMax TechInnostim Tens 1k Unit2016-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237415BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237439BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237507BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237521BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21