Alpine Biomed

GUDID 05704736000567

Digital Ring Electrode x 2, shielded 1m cable, 5-pin DIN connector

Alpine Biomed ApS

Electromyographic needle electrode, single-use

• Primary Device ID: 05704736000567
• NIH Device Record Key: 9eb69983-699e-497f-a95a-9f4b4b2304bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpine Biomed
• Version Model Number: 9013S0302
• Company DUNS: 311231554
• Company Name: Alpine Biomed ApS
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704736000567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934580

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-13

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• 00681490920650: 2-channel EMG/EP Amplifier with 1.7 m cable
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• 00721902428517: 4 CH. AMPLIFIER
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• 00885074326696: 8-channel EMG/EP Amplifier with 1.7 m cable
• 00885074322919: 4 ch Amp- EMG/EP Amplifier with 1.7 m cable
• 00885074322889: 2-channel EMG/EP Amplifier with 1.7 m cable
• 00885074292014: LEADPOINT WORKSTATION 5+3, US
• 00885074292007: LEADPOINT WORKSTATION 5+3, IT
• 00885074291741: LEADPOINT WORKSTATION 5+3, NL
• 00885074291734: LEADPOINT WORKSTATION 5+3, SP
• 00885074291710: LEADPOINT WORKSTATION 5+3, GE
• 00885074291697: LEADPOINT WORKSTATION 5+3, FR
• 00885074291673: LEADPOINT WORKSTATION 5+3, UK
• 00885074291635: G3 KEYPOINT WORKSTATION US
• 00885074291611: KEYPOINT WORKST IT
• 00885074291598: KEYPOINT WORKST NL
• 00885074291574: KEYPOINT WORKST SP
• 00885074291567: G3 KEYPOINT WORKSTATION GE
• 00885074291529: KEYPOINT WORKST FR
• 00885074291499: KEYPOINT WORKST UK
• 05704736019859: FOCUS MAIN UNIT
• 05704736019477: "Keypoint Focus Module: CN Including: - Keypoint Focus main unit with control panel, integrated
• 05704736019408: Macro Stimulator
• 05704736019330: ACTIVE HANDGRIP FOR KP G3
• 05704736019200: Notebook kit, Focus
• 05704736019170: Cable kit for Focus Main Unit
• 05704736019163: KP FOCUS PC SYSTEM, UK 230V SPECIAL LABELING FOR CHINA
• 05704736019156: Keypoint G4, CHINA
• 05704736019149: KP Focus Notebook, UK 230V special for China
• 05704736019064: FRONT END BOX, KEYPOINT G4
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• 05704736018890: LP Focus Workst. system, E
• 05704736018883: LP Focus Workst. system, G
• 05704736018876: LP Focus Workst. system, F