FDA.reportPublic FDA data

ESPIRE

Primary DI
05056394326313
Brand
ESPIRE
Company
HUGH STEEPER LIMITED
Model
Espire DC Cased Electrode Cable
Catalog number
EE-CP-DC
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056394326313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056394326313050563943263135056394326313

GMDN Terms#

Term, Definition table
TermDefinition
Electrical elbow prosthesisAn artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of external motor power applied directly or via a connection with another functional limb component. The control of the device is achieved by an electromechanical switch for the motor that is operated by body movement using straps or cables.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210280350
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05063368529106BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
05063368529502BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05063368529496BATTERY SYSTEM45MM KINISI SH WR HOUSINGMKSW452023-10-04
05063368529519BATTERY SYSTEM50MM KINISI SH WR HOUSING M12BBSW50-M122023-10-04
05055348200228S-CHARGES-Charger - Wall Charger KitSWC22002023-08-08
05055348200068MYO"Myoelectric Hand Quick Disconnect Wrist 6 3/4"" LMYA675LQD2023-08-04
05055348200075MYO"Myoelectric Hand Quick Disconnect Wrist 6 3/4"" RMYA675RQD2023-08-04
05055348248305MYOMyoelectric Hand Quick Disconnect Wrist 7 3/4 RighMYA775RQD2023-08-04
05055348248312MYOMyoelectric Hand Quick Disconnect Wrist 8 1/4 RighMYA825RQD2023-08-04
05056349591032MYOMYO Configuration DeviceMYO-CFG2023-08-04
05056701110802S-CHARGE3500 mAh BATTERYSC3500B2023-08-07
05055348202932MYO50MM SH WR HOUSINGBBSW502023-08-02
05055348244116MYOON/OFF SWITCH AND CHARGE PORTB278042023-08-02
05063368216198MYOSDU CONE ASSEMBLYB307002023-08-02
05055348200181ElectrodeELECTRODE CABLEECA-3002023-07-10
05055348200198ElectrodeELECTRODE CABLEECA-6002023-07-10
05055348200204ElectrodeELECTRODE CABLEECA-10002023-07-10
05055348203304Electrode50Hz ELECTRODEELEC502023-07-10
05055348203311Electrode60Hz ELECTRODEELEC602023-07-10
05055348203328ELECTRODE50Hz ELECTRODE SEAL IN KITELSK502023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16