Sterilance Press2 Pius Disposable Safety Lancet

GUDID 36945630116507

Sterilance Medical (Suzhou) Inc.

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• Primary Device ID: 36945630116507
• NIH Device Record Key: b5f90fb4-4c78-4b9d-829a-4c521cbecccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilance Press2 Pius Disposable Safety Lancet
• Version Model Number: 05-242818
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630116506 [Unit of Use]
GS1	16945630116503 [Primary]
GS1	36945630116507 [Package]; Contains: 16945630116503; Package: [10 Units]; In Commercial Distribution

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: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [Sterilance Press2 Pius Disposable Safety Lancet]

• 36945630116514: 05-243018
• 36945630116507: 05-242818