ITS Model-L6K

GUDID 08800033200048

InTheSmart Co., Ltd.

Endoscope cine camera

• Primary Device ID: 08800033200048
• NIH Device Record Key: f6a8eddd-511e-47a3-9f4d-77065455a03b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITS Model-L6K
• Version Model Number: ITSLC1811, ITSLC1821
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800033200048 [Primary]

FDA Product Code

• FWL: Camera, Cine, Endoscopic, Without Audio

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-21
• Device Publish Date: 2022-11-11

Devices Manufactured by InTheSmart Co., Ltd.

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