neoheel

GUDID 36945630113599

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630113599
• NIH Device Record Key: c2c84567-1bc8-45e6-bad8-74b79e49cae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoheel
• Version Model Number: 1062N
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630113598 [Unit of Use]
GS1	16945630113595 [Primary]
GS1	36945630113599 [Package]; Contains: 16945630113595; Package: carton [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: 2023-05-17
• Device Publish Date: 2023-05-09

On-Brand Devices [neoheel]

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