S-CHARGE SCLAM

GUDID 05056349622026

HUGH STEEPER LIMITED

Myoelectric hand prosthesis
Primary Device ID05056349622026
NIH Device Record Key459fdd00-d2b1-4711-8cd3-fcf956f76c47
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-CHARGE
Version Model Number3500S Battery Pack Lamination Dummy
Catalog NumberSCLAM
Company DUNS210280350
Company NameHUGH STEEPER LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105056349622026 [Primary]

FDA Product Code

IQZHand, External Limb Component, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-12
Device Publish Date2023-07-04

On-Brand Devices [S-CHARGE]

050563496220643500S Switch Kit
050563496220573500S Batteries Kit
05056349622033S-Charge Battery Pack 3500
050563496220263500S Battery Pack Lamination Dummy
05055348244345S-Charge 3500 full kit
05055348200365S-Charge Mounting Frame Kit
05055348200334S-Charge Dummy Kit
05055348200310S-Charge Display Kit
05055348200174S-Charge Hub Kit
050567011108023500 mAh BATTERY
05055348200228S-Charger - Wall Charger Kit

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