ITS Model-L

GUDID 08800033200024

InTheSmart Co., Ltd.

Endoscopic light source unit, line-powered

• Primary Device ID: 08800033200024
• NIH Device Record Key: 21c5f491-c953-4a99-83bb-0a98f7506ca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITS Model-L
• Version Model Number: ITSEL1711
• Company DUNS: 694495825
• Company Name: InTheSmart 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	08800033200024 [Primary]

FDA Product Code

• FCQ: Light Source, Incandescent, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-12-22
• Device Publish Date: 2018-06-15

Devices Manufactured by InTheSmart Co., Ltd.

• 08800033200048 - ITS Model-L6K: 2022-11-21
• 08800033200024 - ITS Model-L: 2021-12-22
• 08800033200024 - ITS Model-L: 2021-12-22