Bipolar electrode

GUDID 04059082014616

SOPRO-COMEG GmbH

Laparoscopic grasping forceps, reusable

• Primary Device ID: 04059082014616
• NIH Device Record Key: a01dcbc9-8e30-4f52-aac4-21d61b07ebc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar electrode
• Version Model Number: 392 993 009
• 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	04059082014616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04059082014616]

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 electrode]

• 04059082014883: 392 993 127
• 04059082014876: 392 993 126
• 04059082014869: 392 993 125
• 04059082014661: 392 993 014
• 04059082014654: 392 993 013
• 04059082014630: 392 993 011
• 04059082014623: 392 993 010
• 04059082014616: 392 993 009
• 04059082014609: 392 993 008