Black Eye

GUDID 08809380059002

The Standard Co., Ltd.

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.

• 08809380057480 - Blue Eye: 2024-08-26
• 08809380050214 - Blue Eye: 2023-07-27
• 08809380059002 - Black Eye: 2020-08-26
• 08809380059002 - Black Eye: 2020-08-26