STERiLANCE Elite Disposable Safety Lancet

GUDID 36945630132460

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630132460
• NIH Device Record Key: 4c8c390a-d420-4a6e-8b47-a3870e1ed6e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiLANCE Elite Disposable Safety Lancet
• Version Model Number: 05-213012
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630132469 [Unit of Use]
GS1	16945630132466 [Primary]
GS1	36945630132460 [Package]; Contains: 16945630132466; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233796

FDA Product Code

• FMK: Single Use Only Blood Lancet With 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: 2024-10-31
• Device Publish Date: 2024-10-23

On-Brand Devices [STERiLANCE Elite Disposable Safety Lancet]

• 06945630126956: 05-211720B
• 06945630126949: 05-212118
• 06945630126932: 05-212618
• 06945630126925: 05-212818
• 06945630126918: 05-213015
• 36945630132453: 05-212812
• 36945630132460: 05-213012
• 36945630132446: 05-212620
• 36945630132439: 05-212118