NA

GUDID 16959664912055

Hangzhou AGS MedTech Co., Ltd.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 16959664912055
• NIH Device Record Key: b41559c8-62e5-4ff8-9c1b-b490fcbfc2f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NA
• Version Model Number: AG-5098-0525
• Company DUNS: 542984702
• Company Name: Hangzhou AGS MedTech Co., Ltd.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06959664912058 [Primary]
GS1	16959664912055 [Package]; Contains: 06959664912058; Package: box [10 Units]; In Commercial Distribution
GS1	26959664912052 [Package]; Package: carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201121

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without 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: 2022-10-17
• Device Publish Date: 2022-10-09

On-Brand Devices [ NA]

• 16959664912123: AG-5099-05
• 16959664912055: AG-5098-0525
• 16959664900830: AG-5063-S2524G
• 16959664900786: AG-5062-N3024G
• 16959664900779: AG-5062-N2524G
• 16959664900762: AG-5062-N2024G
• 16959664900106: AG-5041-2526
• 16959664900021: AG-5041-3526
• 16959664900014: AG-5041-2526