US DIAGNOSTICS

GUDID 56949517070399

Single-Use Safety Lancets, 28G, 100/box

Shandong Lianfa Medical Plastic Products CO.,LTD

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: 56949517070399
• NIH Device Record Key: 6cb00a93-ee4d-4940-8500-806253cea5ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US DIAGNOSTICS
• Version Model Number: Safety lancets 28G
• Company DUNS: 421330121
• Company Name: Shandong Lianfa Medical Plastic Products CO.,LTD
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857513006315 [Primary]
GS1	56949517070399 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222376

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: 2023-06-19
• Device Publish Date: 2023-06-10

On-Brand Devices [US DIAGNOSTICS]

• 00885502007029: Sterile Lancets 30G
• 56949517070399: Single-Use Safety Lancets, 28G, 100/box
• 00857513006667: LD-F-II