MicronJet AS4055

GUDID 17290015928257

A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (600 micron) in length (height). This device can be mounted on any standard syringe (luer slip or luer lock connection)

NANOPASS TECHNOLOGIES LTD

Hypodermic needle, single-use

• Primary Device ID: 17290015928257
• NIH Device Record Key: 4c76df76-3c8e-4fd0-97c8-5037de09d450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicronJet
• Version Model Number: 600
• Catalog Number: AS4055
• Company DUNS: 532670536
• Company Name: NANOPASS TECHNOLOGIES LTD
• Device Count: 30
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter
• Length: 0.6 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015928250 [Unit of Use]
GS1	17290015928257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092746

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2023-08-14
• Device Publish Date: 2023-08-06

On-Brand Devices [MicronJet]

• 17290015928271: A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.8 mm (
• 17290015928257: A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (