xinle XLE3024

GUDID 16950383616361

LANCET GRAY 30G X 2.4MM

Hebei Xinle Sci&Tech Co., Ltd.

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• Primary Device ID: 16950383616361
• NIH Device Record Key: 309d9d2d-b23f-44d0-8efe-fca8b2fc79a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: xinle
• Version Model Number: XL-E 30G
• Catalog Number: XLE3024
• Company DUNS: 529813593
• Company Name: Hebei Xinle Sci&Tech 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: 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: true

Device Dimensions

• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950383616364 [Primary]
GS1	16950383616361 [Package]; Contains: 06950383616364; Package: Carton [50 Units]; In Commercial Distribution
GS1	86950383616360 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221839

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: 2023-09-22
• Device Publish Date: 2023-09-14

On-Brand Devices [xinle]

• 16950383616361: LANCET GRAY 30G X 2.4MM
• 16950383616354: LANCET GRAY 30G X 2.2MM
• 16950383616347: LANCET GRAY 30G X 2.0MM
• 16950383616330: LANCET GRAY 30G X 1.8MM
• 16950383616323: LANCET PURPLE 28G X 2.4MM
• 16950383616316: LANCET PURPLE 28G X 2.2MM
• 16950383616309: LANCET PURPLE 28G X 2.0MM
• 16950383616293: LANCET PURPLE 28G X 1.8MM
• 16950383616286: LANCET GREEN 21G X 2.4MM
• 16950383616279: LANCET GREEN 21G X 2.2MM
• 16950383616262: LANCET GREEN 21G X 2.0MM
• 16950383616255: LANCET GREEN 21G X 1.8MM
• 16950383616248: LANCET GRAY 30G X 2.4MM
• 16950383616231: LANCET GRAY 30G X 2.2MM
• 16950383616224: LANCET GRAY 30G X 2.0MM
• 16950383616217: LANCET GRAY 30G X 1.8MM
• 16950383616200: LANCET PURPLE 28G X 2.4MM
• 16950383616194: LANCET PURPLE 28G X 2.2MM
• 16950383616187: LANCET PURPLE 28G X 2.0MM
• 16950383616170: LANCET PURPLE 28G X 1.8MM
• 16950383616163: LANCET GREEN 21G X 2.4MM
• 16950383616156: LANCET GREEN 21G X 2.2MM
• 16950383616149: LANCET GREEN 21G X 2.0MM
• 86950383616131: LANCET GREEN 21G X 1.8MM