FDA.reportPublic FDA data

Endovapor®

Primary DI
04250337108405
Brand
Endovapor®
Company
Joimax GmbH
Model
REFUSS01
Catalog number
REFUSS01
Device description
Foot Switch joimax® Endovapor®2
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K170358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170358000joimax Endovapor 2Joimax GmbH2017-04-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337108405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337108405042503371084054250337108405

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337118022Intracs®JINTST15JINTST152022-12-30
04250337118039Intracs®JINTST18JINTST182022-12-30
04250337118046Intracs®JINTST23JINTST232022-12-30
04250337116530Joimax® Intracs® EM System Integrated Navigation Tracking & Control SystemJINT01S2021-11-12
04250337116547Joimax® Intracs® EM Panel PCJINTPC11052021-11-12
04250337116554Joimax® Intracs® EM Control UnitJINTCU11152021-11-12
04250337116561Joimax® Intracs® EM Field GeneratorJINTFG11252021-11-12
04250337116585Joimax® Intracs® EM Patient TrackerJINTPT22352021-11-12
04250337116592Joimax® Intracs® EM Sensor ClipJINTSC22052021-11-12
04250337116608Joimax® Intracs® EM Sensor Wire 150JINTSW22152021-11-12
04250337116615Joimax® Intracs® EM Sensor Wire 180JINTSW22182021-11-12
04250337116622Joimax® Intracs® EM Sensor Wire 230JINTSW22232021-11-12
04250337116646Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clampJINTMA11352021-11-12
04250337117667Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clampJINTMAP11362021-11-12
04250337117988Wire cutterJINTWC2021-11-12
04250337117995Joimax® Intracs® EM Y-AdapterJINTYA352021-11-12
04250337118008Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mmJINTDG1828602021-11-12
04250337118015K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mmJKW15152021-11-12
04250337118213Joimax® Intracs® EM Patient Mapper - APJINTPM2245-AP2021-11-12
04250337118220Joimax® Intracs® EM Patient Mapper - LATJINTPM2245-LAT2021-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26