Sterilance LDE3

GUDID 16945630112895

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable

• Primary Device ID: 16945630112895
• NIH Device Record Key: 1c6b877b-d838-4fbd-93d1-6b37d475d8b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilance LDE3
• Version Model Number: 02-1903
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	06945630112898 [Primary]
GS1	16945630112895 [Package]; Contains: 06945630112898; Package: [1 Units]; In Commercial Distribution
GS1	36945630112899 [Package]; Package: [100 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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

• 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
• 26945630122846 - Soft: 2024-02-08
• 26945630122853 - Soft: 2024-02-08
• 26945630122860 - Soft: 2024-02-08