Avecure MWG881

GUDID 00858584002084

Microwave Ablation/Coagulation Generator

MEDWAVES, INC.

Microwave ablation system generator

• Primary Device ID: 00858584002084
• NIH Device Record Key: 813a8e07-79ca-4233-8fbd-54771daa8d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avecure
• Version Model Number: MWG881
• Catalog Number: MWG881
• Company DUNS: 122915353
• Company Name: MEDWAVES, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858584002084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143203

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

On-Brand Devices [Avecure]

• 00858584002220: 16Gauge, Large Antenna Probe, 50cm length
• 00858584002213: 14Gauge, Medium Antenna Probe, 20cm length
• 00858584002206: 16Gauge, Large Antenna Probe, 15cm length
• 00858584002190: 14Gauge, Large Antenna Probe, 30cm length
• 00858584002183: 16Gauge, Small Antenna Probe, 21cm length
• 00858584002176: 16Gauge, Small Antenna Probe, 158cm length
• 00858584002169: 16Gauge, Small Antenna Probe, 90cm length
• 00858584002152: 16Gauge, Small Antenna Probe, 10cm length
• 00858584002145: 14Gauge, Large Antenna Probe, 23cm length
• 00858584002138: 14Gauge, Medium Antenna Probe, 15cm length
• 00858584002114: Extension Cable Set (8 ft.)
• 00858584002091: 14Gauge, Large Antenna Probe, 20cm length
• 00858584002084: Microwave Ablation/Coagulation Generator
• 00858584002077: 16Gauge, Mini Antenna Probe, 15cm length
• 00858584002053: 16Gauge, Small Antenna Probe, 15cm length
• 00858584002022: 14Gauge, Large Antenna Probe, 23cm length
• 00858584002008: 14Gauge, Large Antenna Probe, 15cm length