Sterilance Press Plus

GUDID 36945630114862

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630114862
• NIH Device Record Key: f1372575-7ce0-44f3-bb4c-f9f201f2e894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilance Press Plus
• Version Model Number: 05-232618
• 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	06945630114861 [Unit of Use]
GS1	16945630114868 [Primary]
GS1	36945630114862 [Package]; Contains: 16945630114868; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221521

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: 2022-11-21
• Device Publish Date: 2022-11-11

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

• 36945630136178 - TRANSTEK: 2025-04-30
• 36945630136147 - TRANSTEK: 2025-04-30
• 36945630136154 - TRANSTEK: 2025-04-30
• 26945630136164 - TRANSTEK: 2025-04-30
• 36945630135805 - Bard: 2025-03-31
• 06945630135316 - STERiLANCE OneStep Lancing Device: 2025-03-20
• 06945630114083 - Bard: 2025-03-10
• 36945630135324 - STERiLANCE OneStep Lancing Device: 2025-02-26