Genteel

GUDID 16934047903165

Ningbo Medsun Medical Co., Ltd.

Blood lancet, single-use

• Primary Device ID: 16934047903165
• NIH Device Record Key: ebc40d5f-e20e-45ea-949d-2bfae701f326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genteel
• Version Model Number: BYY4 26G
• Company DUNS: 545194383
• Company Name: Ningbo Medsun Medical Co., Ltd.
• Device Count: 100
• 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	06934047903168 [Unit of Use]
GS1	16934047903165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232330

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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: 2024-11-13
• Device Publish Date: 2024-11-05

On-Brand Devices [Genteel]

• 16934047903172: BYY4 26G
• 16934047903165: BYY4 26G