GA-E

GUDID 18800067700047

AGNES MEDICAL CO., LTD.

Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode Intradermal radio-frequency ablation system needle electrode

• Primary Device ID: 18800067700047
• NIH Device Record Key: 1116e385-1af6-4ea0-a444-92ed1dffa1d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GA-E
• Version Model Number: GA-E
• Company DUNS: 695070346
• Company Name: AGNES MEDICAL CO., LTD.
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com
• Phone: +823180209717
• Email: jglee@agnesmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800067700040 [Primary]
GS1	18800067700047 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171707

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

Devices Manufactured by AGNES MEDICAL CO., LTD.

• 08800067700002 - AGNES: 2023-07-24
• 08800067700019 - AGNES-S: 2023-07-24
• 18800067700023 - GA-C: 2023-07-24
• 18800067700030 - GA-I: 2023-07-24
• 18800067700047 - GA-E: 2023-07-24
• 18800067700047 - GA-E: 2023-07-24
• 18800067700054 - GA-S: 2023-07-24
• 18800067700061 - GA-W3A: 2023-07-24
• 18800067700078 - GA-F3A: 2023-07-24