MINICOLLECT PIXIE Heel Incision Safety Lancet

GUDID 06945630109829

MINICOLLECT PIXIE Heel Incision Safety Lancet,1.0*2.5mm,50Lancets/box

Sterilance Medical (Suzhou) Inc.

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• Primary Device ID: 06945630109829
• NIH Device Record Key: d6551504-0620-42c1-b62c-b135ff74c0cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINICOLLECT PIXIE Heel Incision Safety Lancet
• Version Model Number: 450527
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630109829 [Unit of Use]
GS1	16945630109826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210745

FDA Product Code

• FMK: Lancet, Blood

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-26
• Device Publish Date: 2021-04-20

On-Brand Devices [MINICOLLECT PIXIE Heel Incision Safety Lancet]

• 06945630109843: MINICOLLECT PIXIE Heel Incision Safety Lancet,0.65*1.40mm,50Lancets/box
• 06945630109836: MINICOLLECT PIXIE Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box
• 06945630109829: MINICOLLECT PIXIE Heel Incision Safety Lancet,1.0*2.5mm,50Lancets/box