Black Eye

Basic Information

• Brand Name: Black Eye
• Primary DI: 08809380059002
• Version / Model: TS-205
• Company Name: The Standard Co., Ltd.
• Labeler DUNS: 557812775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-18
• Public Version: 4
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: f7d3ccf1-47cc-4d40-9e2a-a083f4c9d80d

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: Yes
• 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
NBG	Marker, Colon	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17828	Tissue marking ink	A sterile liquid substance intended to be injected into tissue to identify lesions; it is also used externally on the skin to mark incision sites. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809380059002	GS1
Package	08809380050771	GS1	Canister	12	Not in Commercial Distribution	2021-07-07
Package	18809380050778	GS1	Carton Box	12	Not in Commercial Distribution	2021-07-07
Package	08809380059606	GS1	Canister	10	In Commercial Distribution
Package	18809380059603	GS1	Carton Box	12	In Commercial Distribution