STERiLANCE Press2 Disposable Safety Lancet

GUDID 36945630132507

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630132507
• NIH Device Record Key: c27a9b3c-11bf-48ec-bb20-cd54f9b73fde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiLANCE Press2 Disposable Safety Lancet
• Version Model Number: 05-063012
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630132506 [Unit of Use]
GS1	16945630132503 [Primary]
GS1	36945630132507 [Package]; Contains: 16945630132503; Package: [10 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: 2024-10-31
• Device Publish Date: 2024-10-23

On-Brand Devices [STERiLANCE Press2 Disposable Safety Lancet]

• 36945630115081: 05-063018
• 36945630115074: 05-062818
• 36945630131081: 05-063018
• 36945630132408: 05-062122
• 36945630132392: 05-062122
• 36945630132507: 05-063012
• 36945630132491: 05-062812
• 36945630132484: 05-062620
• 36945630132477: 05-062118