MINICOLLECT PIXIE Heel Incision Safety Lancet

GUDID 06945630109843

MINICOLLECT PIXIE Heel Incision Safety Lancet,0.65*1.40mm,50Lancets/box

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 06945630109843
• NIH Device Record Key: 0c133927-6065-4522-b715-8173c0de37f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINICOLLECT PIXIE Heel Incision Safety Lancet
• Version Model Number: 450525
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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	06945630109843 [Unit of Use]
GS1	16945630109840 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-29
• Device Publish Date: 2021-04-21

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