STERiJECT OPHTHALMIC NEEDLE™

GUDID 04571603050083

TSK LABORATORY INTERNATIONAL JAPAN K.K.

Ophthalmic needle, single-use

• Primary Device ID: 04571603050083
• NIH Device Record Key: 67d24da4-e3f8-4c38-a6f1-ea68aff618d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiJECT OPHTHALMIC NEEDLE™
• Version Model Number: VHPC-29013E
• Company DUNS: 717605253
• Company Name: TSK LABORATORY INTERNATIONAL JAPAN K.K.
• Device Count: 1
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04571603050083 [Package]; Contains: 04573545740107; Package: Inner Box [50 Units]; In Commercial Distribution
GS1	04573545740107 [Primary]
GS1	14571603050080 [Package]; Contains: 04573545740107; Package: Carton [4800 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242073

FDA Product Code

• QYM: Ophthalmic Needle

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: 2025-07-22
• Device Publish Date: 2025-07-14

On-Brand Devices [STERiJECT OPHTHALMIC NEEDLE™ ]

• 04571603050083: VHPC-29013E
• 04571603050076: VHPC-29010E