VedBasket, Stone Extraction Baskets

GUDID 16970057573028

Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: 16970057573028
• NIH Device Record Key: 5aec2c14-89e8-48bd-acb4-8b8a7f14f7b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VedBasket, Stone Extraction Baskets
• Version Model Number: VDK-BAS-23-200-35-S4-A
• Company DUNS: 544430136
• Company Name: Jiangsu Vedkang Medical Science and 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	06970057573021 [Primary]
GS1	16970057573028 [Package]; Contains: 06970057573021; Package: BOX [1 Units]; In Commercial Distribution
GS1	26970057573025 [Package]; Contains: 06970057573021; Package: BOX [2 Units]; In Commercial Distribution
GS1	56970057573026 [Package]; Package: carton [10 Units]; In Commercial Distribution
GS1	66970057573023 [Package]; Package: carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230598

FDA Product Code

• LQR: Dislodger, Stone, Biliary

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: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [VedBasket, Stone Extraction Baskets]

• 16970057573028: VDK-BAS-23-200-35-S4-A
• 16970057573011: VDK-BAS-23-200-30-S4-A