MiroCam Capusle Endoscope System

GUDID 18809260260358

IntroMedic Co., LTD.

Video capsule endoscopy system capsule

• Primary Device ID: 18809260260358
• NIH Device Record Key: 3946c1d4-edda-409c-a404-7f1b5cf28b59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiroCam Capusle Endoscope System
• Version Model Number: MC2000-B
• Company DUNS: 631065794
• Company Name: IntroMedic Co., LTD.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• 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	08809260260153 [Unit of Use]
GS1	08809260260351 [Primary]
GS1	18809260260358 [Package]; Contains: 08809260260351; Package: Large box [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170438

FDA Product Code

• NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-02-12

On-Brand Devices [MiroCam Capusle Endoscope System]

• 08809260260436: Package System(MC2000-B Capsule and MR2000 Receiver)
• 18809260260358: MC2000-B