Sterilance SteriHeel Plus Heel Incision Safety Lancet

GUDID 36945630115005

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630115005
• NIH Device Record Key: bdeae7fb-5e7f-44c5-a38c-ba3edcaa9a7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilance SteriHeel Plus Heel Incision Safety Lancet
• Version Model Number: 30-108575
• 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	06945630115004 [Unit of Use]
GS1	16945630115001 [Primary]
GS1	36945630115005 [Package]; Contains: 16945630115001; 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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Sterilance SteriHeel Plus Heel Incision Safety Lancet]

• 06945630110290: Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.65*1.40mm.
• 06945630110283: Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm.
• 36945630115012: 30-101428
• 36945630115005: 30-108575
• 36945630114992: 30-101025
• 06945630125522: 30-106514