Electrode

GUDID 04059082025933

SOPRO-COMEG GmbH

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 04059082025933
• NIH Device Record Key: 798d1945-7773-4d47-9097-7eb9de873c4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrode
• Version Model Number: 395 400 026 C
• 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	04059082025933 [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

[04059082025933]

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 [Electrode]

• 04059082033341: 395 400 025
• 04059082033334: 395 400 024
• 04059082033327: 395 400 023
• 04059082032405: 395 400 031
• 04059082032399: 395 400 029
• 04059082032382: 395 400 028
• 04059082032375: 395 400 027
• 04059082032368: 395 400 026
• 04059082031248: 395 400 048
• 04059082031231: 395 400 047
• 04059082031224: 395 400 046
• 04059082031217: 395 400 017
• 04059082031200: 395 400 015
• 04059082031194: 395 400 014
• 04059082031187: 395 400 013
• 04059082031170: 395 400 012
• 04059082031163: 395 400 011
• 04059082031156: 395 400 010
• 04059082031149: 395 400 009
• 04059082031132: 195 810 150
• 04059082031125: 195 810 140
• 04059082031118: 195 810 130
• 04059082031101: 195 810 120
• 04059082031088: 195 400 101
• 04059082031071: 195 400 100
• 04059082031064: 195 100 052
• 04059082031057: 195 100 051
• 04059082031040: 195 100 050
• 04059082031033: 195 100 040
• 04059082031026: 195 100 030
• 04059082031019: 195 100 025
• 04059082031002: 195 100 020
• 04059082030999: 195 100 010
• 04059082030982: 195 100 008
• 04059082030975: 195 100 007
• 04059082030968: 195 100 002
• 04059082030951: 195 100 001
• 04059082030944: 195 100 000
• 04059082027302: 397 500 016
• 04059082027265: 397 500 009
• 04059082027258: 397 500 008
• 04059082027241: 397 500 007
• 04059082027227: 397 500 001
• 04059082027210: 397 500 000
• 04059082026077: 395 400 048 C
• 04059082026060: 395 400 047 C
• 04059082026053: 395 400 046 C
• 04059082025988: 395 400 031 C
• 04059082025964: 395 400 029 C
• 04059082025957: 395 400 028 C