STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)

GUDID 04571603050038

TSK LABORATORY INTERNATIONAL JAPAN K.K.

Ophthalmic needle, single-use

• Primary Device ID: 04571603050038
• NIH Device Record Key: 9b586878-ee30-4d46-8179-721983f82c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)
• Version Model Number: VLDS-32004
• 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	04571603050038 [Package]; Contains: 04573545740039; Package: Inner Box [50 Units]; In Commercial Distribution
GS1	04573545740039 [Primary]
GS1	14571603050035 [Package]; Contains: 04573545740039; 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™ Low Dead Space (LDS)]

• 04571603050069: VLDS-30013E
• 04571603050052: VLDS-32013
• 04571603050045: VLDS-32009
• 04571603050038: VLDS-32004
• 04571603050021: VLDS-33009
• 04571603050014: VLDS-02009