Bipolar HF cable

GUDID 04059082012995

SOPRO-COMEG GmbH

Electrical-only medical device connection cable, reusable

• Primary Device ID: 04059082012995
• NIH Device Record Key: d7e3320a-6f9c-450f-8146-584beb7391d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar HF cable
• Version Model Number: 390 845 000
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG 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: true
• 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	04059082012995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971881

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Sterilization

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

[04059082012995]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Bipolar HF cable]

• 04059082013039: 390 865 000
• 04059082013022: 390 863 000
• 04059082012995: 390 845 000
• 04059082012988: 390 843 000
• 04059082012971: 390 835 000
• 04059082012964: 390 833 000
• 04059082012957: 390 825 000
• 04059082012940: 390 823 000
• 04059082012933: 390 815 000
• 04059082012926: 390 813 000
• 04059082012919: 390 805 000
• 04059082012902: 390 803 000