Remote Electrode

GUDID 04064411005296

Otto Bock Healthcare Products GmbH

Myoelectric hand prosthesis

• Primary Device ID: 04064411005296
• NIH Device Record Key: b26430ac-2d79-4f48-9abd-3a40b177f478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remote Electrode
• Version Model Number: 13E401=G90-60
• Company DUNS: 300802068
• Company Name: Otto Bock Healthcare Products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04064411005296 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [Remote Electrode]

• 04032767940790: 13E401=G90-60-OB
• 04032767940783: 13E401=G90-60
• 04032767940776: 13E401=G90-50-OB
• 04032767940769: 13E401=G90-50
• 04032767940752: 13E401=G140-60-OB
• 04032767940745: 13E401=G140-60
• 04032767940738: 13E401=G140-50-OB
• 04032767940721: 13E401=G140-50
• 04032767940714: 13E400=G90-60-OB
• 04032767940707: 13E400=G90-60
• 04032767940691: 13E400=G90-50-OB
• 04032767938155: 13E400=G90-50
• 04032767937462: 13E400=G140-60-OB
• 04032767937455: 13E400=G140-60
• 04032767937448: 13E400=G140-50-OB
• 04032767937431: 13E400=G140-50
• 04064411005302: 13E401=G90-60-OB
• 04064411005296: 13E401=G90-60
• 04064411005289: 13E401=G90-50-OB
• 04064411005272: 13E401=G90-50
• 04064411005265: 13E401=G140-60-OB
• 04064411005258: 13E401=G140-60
• 04064411005241: 13E401=G140-50-OB
• 04064411005234: 13E401=G140-50
• 04064411005227: 13E400=G90-60-OB
• 04064411005210: 13E400=G90-60
• 04064411005203: 13E400=G90-50-OB
• 04064411005197: 13E400=G90-50
• 04064411005180: 13E400=G140-60-OB
• 04064411005173: 13E400=G140-60
• 04064411005166: 13E400=G140-50-OB
• 04064411005159: 13E400=G140-50