STERiJECT TM

GUDID 14571225314195

TSK STERiJECT Premium Disposable Hypodermic Needle

TSK LABORATORY, JAPAN

Hypodermic needle, single-use

• Primary Device ID: 14571225314195
• NIH Device Record Key: e5a69736-f496-407c-b0fc-ae6be056ecf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiJECT TM
• Version Model Number: HPC-27019I
• Company DUNS: 690646096
• Company Name: TSK LABORATORY, JAPAN
• 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

• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 0.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04571225314037 [Unit of Use]
GS1	04571225314198 [Primary]
GS1	14571225314195 [Package]; Contains: 04571225314198; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970370

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: 2024-06-18
• Device Publish Date: 2024-06-10

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