FDA.reportPublic FDA data

Spring Op Hand

Primary DI
05056349560687
Brand
Spring Op Hand
Company
HUGH STEEPER LIMITED
Model
Spring Operated Hand 7 3/4 Right - 1/2 X 20 Tpi
Catalog number
SPA775RNA
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRAHand, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRAHand, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056349560687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056349560687050563495606875056349560687

GMDN Terms#

Term, Definition table
TermDefinition
Body-powered hand prosthesisAn artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device moves as the result of connecting straps/cables or other mechanism powered by the movement of body segments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210280350
Device count
1
Premarket exempt
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719883463531TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
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