Black Eye

GUDID 08809380059002

The Standard Co., Ltd.

Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink

• Primary Device ID: 08809380059002
• NIH Device Record Key: f7d3ccf1-47cc-4d40-9e2a-a083f4c9d80d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Eye
• Version Model Number: TS-205
• Company DUNS: 557812775
• Company Name: The Standard Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	08809380050771 [Package]; Package: Canister [12 Units]; In Commercial Distribution
GS1	08809380059002 [Primary]
GS1	08809380059606 [Package]; Package: Canister [10 Units]; In Commercial Distribution
GS1	18809380050778 [Package]; Contains: 08809380050771; Package: Carton Box [12 Units]; In Commercial Distribution
GS1	18809380059603 [Package]; Contains: 08809380059606; Package: Carton Box [12 Units]; In Commercial Distribution

FDA Product Code

• NBG: Marker, Colon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-08-26
• Device Publish Date: 2019-01-18

Devices Manufactured by The Standard Co., Ltd.

• 08809380050214 - Blue Eye: 2023-07-27
• 08809380059002 - Black Eye: 2020-08-26
• 08809380059002 - Black Eye: 2020-08-26