WONTECH Surgical Optic Fibers

GUDID 08800022301800

BA400 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)

WONTECH CO.,LTD

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

• Primary Device ID: 08800022301800
• NIH Device Record Key: 9cfb5a63-682e-4b58-9155-1e58d38d76ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WONTECH Surgical Optic Fibers
• Version Model Number: BA400
• 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	08800022301800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241643

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: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [WONTECH Surgical Optic Fibers]

• 08800022301831: BA600R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022301824: BA400R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022301817: BA600 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022301800: BA400 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)