FDA.reportPublic FDA data

Wrist

Primary DI
05056349512471
Brand
Wrist
Company
HUGH STEEPER LIMITED
Model
Friction Housing 45mm M12
Catalog number
NHD55109-M12
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISZUnit, Wrist, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISZUnit, Wrist, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056349512471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056349512471050563495124715056349512471

GMDN Terms#

Term, Definition table
TermDefinition
Passive wrist prosthesisAn artificial substitute for a missing wrist used as part of an upper-limb external prosthetic system and designed to be positioned by the application of external force.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650884Explorer Hold Lock Modulemacu4 GmbHISZ2026-03-23
04262429650006Explorer Bike Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650013Explorer Bike Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650020Explorer Ball Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650037Explorer Ball Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650044Explorer Ball Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650051Explorer Ball Module SML with spacermacu4 GmbHISZ2025-11-23
04262429650068Explorer Swim Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650075Explorer Swim Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650082Explorer Twin Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650099Explorer Twin Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650105Explorer Twin Module LRG without spacermacu4 GmbHISZ2025-11-23
04262429650112Explorer Twin Module LRG with spacermacu4 GmbHISZ2025-11-23
04262429650136Explorer Ring STDmacu4 GmbHISZ2025-11-23
04262429650143Explorer Pinch Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650150Explorer Pinch Module spacermacu4 GmbHISZ2025-11-23
04262429650297Explorer Ring EXPmacu4 GmbHISZ2025-11-23
04262429650303Explorer Hold Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650310Explorer Hold Module spacermacu4 GmbHISZ2025-11-23
09421037390383Low Profile Lamination Kit, CX, 50mm TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390451MC Seal Ring Kit, Medium/Large, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390505TASKA Seal Ring Kit, 50mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785425MC Seal Ring Kit, Medium/Large, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785432TASKA Seal Ring Kit, 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785944MC Seal Ring Kit, Small, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785951MC Seal Ring Kit, Small, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785982TASKA Seal Ring Kit, 45mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785999TASKA Seal Ring Kit, 45mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390390TASKA Lamination Collar Kit (6-band), 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-28
09421037390406TASKA Lamination Collar Kit (6-band), 50mm, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-28