STERiLANCE OneStep Lancing Device

GUDID 06945630135316

Sterilance Medical (Suzhou) Inc.

Blood lancet, single-use

• Primary Device ID: 06945630135316
• NIH Device Record Key: 50c5f4b2-a33a-4bfb-b93f-423ddc1562ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiLANCE OneStep Lancing Device
• Version Model Number: 01-1930
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 50
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630135316 [Unit of Use]
GS1	16945630135313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K244031

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: 2025-03-20
• Device Publish Date: 2025-03-12

On-Brand Devices [STERiLANCE OneStep Lancing Device]

• 36945630135324: 02-2401
• 06945630135316: 01-1930