Betters (Suzhou)Medical Co., Ltd.

GUDID 06975283420019

Betters (Suzhou)Medical Co., Ltd.

Microwave ablation system probe, non-powered

• Primary Device ID: 06975283420019
• NIH Device Record Key: 8559a48c-1f61-413b-9e80-c4e894dcd7f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Betters (Suzhou)Medical Co., Ltd.
• Version Model Number: T-1608
• Company DUNS: 551474420
• Company Name: Betters (Suzhou)Medical 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975283420019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232241

FDA Product Code

• NEY: System, Ablation, Microwave And 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: 2023-12-25
• Device Publish Date: 2023-12-16

On-Brand Devices [Betters (Suzhou)Medical Co., Ltd.]

• 06975283422013: T-1408
• 06975283420095: BD-GT
• 06975283420064: L-2018
• 06975283420057: L-2015
• 06975283420040: L-1818
• 06975283420033: L-1815
• 06975283420026: T-1610
• 06975283420019: T-1608
• 06975283420002: T-1410
• 06975283420088: CWZ-1620
• 06975283420071: CWZ-1615