Air Gap Fiber

GUDID 08800022303606

AG550 of Air Gap Fiber Series AG550, AG365, AG275

WONTECH CO.,LTD

General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 08800022303606
• NIH Device Record Key: 42469773-c5be-4dcd-a825-5a6836adfe32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Gap Fiber
• Version Model Number: AG550
• Company DUNS: 695658263
• Company Name: WONTECH 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: 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	08800022303606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232106

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-02-09
• Device Publish Date: 2024-02-01

On-Brand Devices [Air Gap Fiber]

• 08800022303613: AG365 of Air Gap Fiber Series AG550, AG365, AG275
• 08800022303606: AG550 of Air Gap Fiber Series AG550, AG365, AG275
• 08800022303620: AG275 of Air Gap Fiber Series AG550, AG365, AG275