MiroCam Capsule Endoscope System

GUDID 18809260260570

IntroMedic Co., LTD.

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• Primary Device ID: 18809260260570
• NIH Device Record Key: b24b064b-d92c-4b5d-92dd-02af7b5f94f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiroCam Capsule Endoscope System
• Version Model Number: MC2000-B
• Company DUNS: 631065794
• Company Name: IntroMedic Co., LTD.
• Device Count: 10
• 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	08809260260573 [Primary]
GS1	18809260260570 [Package]; Contains: 08809260260573; Package: Large box [20 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-17
• Device Publish Date: 2020-09-09

On-Brand Devices [MiroCam Capsule Endoscope System]

• 08809260260498: Package system(MC1600-B Capsule and MR2000 Receiver)
• 08809260260320: MC1600-B
• 98809260260446: Package system(MC1200-B capsule, MR2000 receiver)
• 08809260260290: MC1200-B
• 08809260260269: MC1000-B
• 08809260260191: MR2000
• 18809260260587: MC1600-B
• 18809260260570: MC2000-B
• 18809260260563: MC1200-B