STERiLANCE Elite Pro Disposable Safety Lancet

GUDID 06945630126994

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 06945630126994
• NIH Device Record Key: 6ce93acd-8981-4c57-9b4c-373bad41353d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiLANCE Elite Pro Disposable Safety Lancet
• Version Model Number: 05-2921A
• 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	06945630126994 [Unit of Use]
GS1	16945630126991 [Primary]

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: 2024-05-30
• Device Publish Date: 2024-05-22

On-Brand Devices [STERiLANCE Elite Pro Disposable Safety Lancet]

• 06945630126994: 05-2921A
• 06945630126987: 05-2923A
• 06945630126970: 05-2926A
• 06945630126963: 05-2928A