Soft

GUDID 26945630122846

Sterilance Medical (Suzhou) Inc.

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 26945630122846
• NIH Device Record Key: d4fffe65-48d0-49b2-a766-d1106d62372a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft
• Version Model Number: 01-0130
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 10
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630122842 [Unit of Use]
GS1	16945630122849 [Primary]
GS1	26945630122846 [Package]; Contains: 16945630122849; Package: [200 Units]; In Commercial Distribution
GS1	36945630122843 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• QRK: Single Use Only Blood Lancet Without 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: 2024-02-08
• Device Publish Date: 2024-01-31

On-Brand Devices [Soft ]

• 26945630122877: 01-0128
• 26945630122860: 01-0128
• 26945630122853: 01-0130
• 26945630122846: 01-0130