neoheel

GUDID 36945630121808

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630121808
• NIH Device Record Key: 40b51b4d-2cf0-4d21-812e-8daf1957e34d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoheel
• Version Model Number: 1061P
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 50
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630121807 [Unit of Use]
GS1	16945630121804 [Primary]
GS1	36945630121808 [Package]; Contains: 16945630121804; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210745

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: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [neoheel]

• 36945630113629: 1063T
• 36945630113612: 1061P
• 36945630113605: 1060M
• 36945630113599: 1062N
• 36945630124106: 1063T
• 06945630121821: 1060M
• 36945630121815: 1062N
• 36945630121808: 1061P