PurCel Labs Safety Lancets Push-Button (30G x 1.5mm)

GUDID 00810143550146

LANCET, PUSH-BTN SFTY, AUTO RETRACT, 30G NDL 1.5MM, FIXED DEPTH, LIGHT GREEN (100/BX)

Purcel Labs LLC

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 00810143550146
• NIH Device Record Key: 0a4e892a-422e-4c99-8751-3cef7d15a845
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PurCel Labs Safety Lancets Push-Button (30G x 1.5mm)
• Version Model Number: 1100-100
• Company DUNS: 127672531
• Company Name: Purcel Labs LLC
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810143550139 [Primary]
GS1	00810143550146 [Package]; Contains: 00810143550139; Package: Case [20 Units]; In Commercial Distribution
GS1	10810143550136 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222090

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: 2023-08-02
• Device Publish Date: 2023-07-25

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