Sterilance Flex3 Depth Adjustable Safety Lancet

GUDID 36945630111922

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630111922
• NIH Device Record Key: 3ddc29cb-0b79-462e-9074-b08e0cea6e82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilance Flex3 Depth Adjustable Safety Lancet
• Version Model Number: 05-1528A
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630111921 [Unit of Use]
GS1	16945630111928 [Primary]
GS1	36945630111922 [Package]; Contains: 16945630111928; Package: [1000 Units]; Discontinued: 2022-03-10; Not 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: 2022-03-18
• Device Publish Date: 2022-03-10

On-Brand Devices [Sterilance Flex3 Depth Adjustable Safety Lancet]

• 06945630109010: Sterilance Flex3 Depth Adjustable Safety Lancet,26G 1.3mm/1.8mm/2.3mm,100Lancets/box
• 36945630111977: 05-052618
• 36945630111922: 05-1528A
• 36945630111915: 05-1530A
• 36945630111908: 05-1526A
• 36945630111892: 05-1523A