Monopolar electrode

GUDID 04059082015712

SOPRO-COMEG GmbH

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 04059082015712
• NIH Device Record Key: 4f3ad725-9627-49fa-a3c3-ebf2e8b348e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monopolar electrode
• Version Model Number: 392 999 659
• 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	04059082015712 [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

[04059082015712]

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 [Monopolar electrode]

• 04059082015866: 392 999 915
• 04059082015859: 392 999 914
• 04059082015842: 392 999 913
• 04059082015835: 392 999 912
• 04059082015828: 392 999 910
• 04059082015811: 392 999 905
• 04059082015804: 392 999 904
• 04059082015798: 392 999 903
• 04059082015781: 392 999 902
• 04059082015774: 392 999 900
• 04059082015712: 392 999 659
• 04059082015705: 392 999 658
• 04059082015699: 392 999 657
• 04059082015644: 392 999 616
• 04059082015637: 392 999 614
• 04059082015620: 392 999 613
• 04059082015613: 392 999 612
• 04059082015606: 392 999 610
• 04059082015590: 392 999 606
• 04059082015576: 392 999 604
• 04059082015569: 392 999 603
• 04059082015552: 392 999 602
• 04059082015545: 392 999 600
• 04059082015538: 392 999 515
• 04059082015521: 392 999 514
• 04059082015514: 392 999 513
• 04059082015507: 392 999 512
• 04059082015491: 392 999 510
• 04059082015484: 392 999 505
• 04059082015477: 392 999 504
• 04059082015460: 392 999 503
• 04059082015453: 392 999 502
• 04059082015446: 392 999 500