Blue Eye

Basic Information

• Brand Name: Blue Eye
• Primary DI: 08809380057473
• Version / Model: TS-910
• Company Name: THE STANDARD CO.,LTD.
• Labeler DUNS: 557812775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-16
• Public Version: 2
• Public Version Date: 2024-09-05
• Public Version Status: Update
• Public Device Record Key: c19f240a-f532-4c3c-84cb-27ad2ff70b2b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PLL	Submucosal Injection Agent	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62217	Submucosal lift solution	A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g., polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. It is typically a gel-like emulsion (e.g., containing fats and/or salts), and may include a dye. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08809380057480	GS1	Paper box	5	In Commercial Distribution
Primary	08809380057473	GS1
Package	18809380057487	GS1	Carton Box	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K241591	000