SteriLance Impress safety lancet 28G 1.8mm

GUDID 36945630123321

Sterilance Medical (Suzhou) Inc.

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• Primary Device ID: 36945630123321
• NIH Device Record Key: 90cb9b0c-eb57-48f0-a644-f01c33f99c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriLance Impress safety lancet 28G 1.8mm
• Version Model Number: 05-172818
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630123320 [Unit of Use]
GS1	16945630123327 [Primary]
GS1	36945630123321 [Package]; Contains: 16945630123327; Package: [20 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: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

• 26945630125779 - PRESS DISPOSABLE SAFETY LANCET: 2024-05-09
• 36945630125752 - EXALANCE LDE4 Lancing Device: 2024-05-02
• 06945630125522 - STERiLANCE SteriHeel Plus Heel Incision Safety Lancet: 2024-04-17
• 26945630125120 - Disposable Safety Lancet Press2: 2024-04-08
• 36945630121808 - neoheel: 2024-02-16
• 36945630121815 - neoheel: 2024-02-16
• 06945630121821 - neoheel: 2024-02-16
• 36945630124106 - neoheel: 2024-02-16