Pantheris

GUDID 06975417183865

Zylox-Tonbridge Medical Technology Co., Ltd.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 06975417183865
• NIH Device Record Key: a6c1518d-8f56-4112-82f2-1808dcd6f45a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pantheris
• Version Model Number: A400X
• Company DUNS: 542983873
• Company Name: Zylox-Tonbridge Medical Technology 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975417183865 [Primary]

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

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: 2026-03-30
• Device Publish Date: 2026-03-21

On-Brand Devices [Pantheris]

• 06975417183889: A110-LV
• 06975417183872: A140-SV
• 06975417183865: A400X
• 06975417183858: A400