Monopolar HF cable

GUDID 04059082026657

SOPRO-COMEG GmbH

Electrical-only medical device connection cable, reusable

• Primary Device ID: 04059082026657
• NIH Device Record Key: 80a7188b-a1b9-45d2-bf88-9bf0ad34bc8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monopolar HF cable
• Version Model Number: 395 502 502
• 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	04059082026657 [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

[04059082026657]

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 HF cable]

• 04059082026718: 395 502 508
• 04059082026701: 395 502 507
• 04059082026695: 395 502 506
• 04059082026688: 395 502 505
• 04059082026671: 395 502 504
• 04059082026664: 395 502 503
• 04059082026657: 395 502 502
• 04059082026640: 395 502 501
• 04059082026633: 395 502 500
• 04059082009421: 195 200 004
• 04059082009414: 195 200 003
• 04059082009407: 195 200 002
• 04059082009391: 195 200 001