FDA.reportPublic FDA data

VESALIUS round and small single eletric pedal

Primary DI
08034055294574
Brand
VESALIUS round and small single eletric pedal
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
L=4m
Catalog number
2504012
Published
2017-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034055294574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034055294574080340552945748034055294574

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.

Regulatory Flags#

DUNS number
435331459
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034055295861VESALIUS STERILE footswitch handle with ballSterile, L=3m25020192016-09-24
08034055293850VESALIUS STERILE single-use endoscopic probe for ablationSTERILE26100042016-09-24
08034055291276VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292019-11-11
08034055295755VESALIUS STERILE Short fingerswitch handleSterile, L=3m25020182016-09-24
08034055296738VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11
08034055290224VESALIUs Footswitch handleReusable, L=3m25020012016-09-24
08034055290231VESALIUS Fingerswitch handleReusable, L=3m 25020032016-09-24
08034055290255VESALIUS STERILE fingerswitch handleSterile, L=3m25020062016-09-24
08034055290309VESALIUS Fingerswitch handleReusable; L=5m 25020132016-09-24
08034055294628VESALIUS STERILE Short fingerswitch handleSterile, L=3m25020182016-09-24
08034055291184VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192019-11-11
08034055296752VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192019-11-11
08034055296806VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11
08034055290163VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192016-09-24
08034055290200VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232016-09-24
08034055296059VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292016-09-24
8034055297681VESALIUS STERILE single-use endoscopic probe for ablationSTERILE26100042016-09-24
08034055290361VESALIUS single-use neutral insulated plate for adultsSingle-use25030032016-09-24
08034055293157VESALIUS round bipolar connector for ESSENTIALL=3m2506007E2018-12-31
08034055298213VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292019-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17