Injection Needle

GUDID 16970057576166

Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

General-purpose endoscopic needle, single-use

• Primary Device ID: 16970057576166
• NIH Device Record Key: 4dc735de-1ee9-47d7-89be-d483c89a1546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injection Needle
• Version Model Number: VDK-IN-23-230-2206-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	06970057576169 [Primary]
GS1	16970057576166 [Package]; Contains: 06970057576169; Package: BOX [10 Units]; In Commercial Distribution
GS1	56970057576164 [Package]; Package: carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213914

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

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 [Injection Needle]

• 16970057576241: VDK-IN-23-230-2505-A
• 16970057576166: VDK-IN-23-230-2206-A
• 16970057576067: VDK-IN-23-230-2506-A