Avecure 16-50-07-35

GUDID 00858584002220

16Gauge, Large Antenna Probe, 50cm length

MEDWAVES, INC.

Microwave ablation system probe

• Primary Device ID: 00858584002220
• NIH Device Record Key: 079b384a-283d-4d44-8263-8207818b8c4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avecure
• Version Model Number: 16-50-07-35
• Catalog Number: 16-50-07-35
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858584002220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143203

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

Sterilization

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

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

[00858584002220]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• 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