Blue Eye

GUDID 08809380057480

The Standard Co., Ltd.

Submucosal lift solution

• Primary Device ID: 08809380057480
• NIH Device Record Key: c19f240a-f532-4c3c-84cb-27ad2ff70b2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue Eye
• Version Model Number: TS-910
• Company DUNS: 557812775
• Company Name: The Standard Co., Ltd.
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809380057473 [Primary]
GS1	08809380057480 [Package]; Contains: 08809380057473; Package: Paper box [5 Units]; In Commercial Distribution
GS1	18809380057487 [Package]; Package: Carton Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241591

FDA Product Code

• PLL: Submucosal Injection Agent

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: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [Blue Eye]

• 08809380050214: TS-905
• 08809380057480: TS-910