Sitzmarks Radiopaque Markers

GUDID 00610858081139

KONSYL PHARMACEUTICALS, INC.

Gastrointestinal telemetric monitoring system capsule, non-sterile

• Primary Device ID: 00610858081139
• NIH Device Record Key: 2e6282fc-9b44-4af1-9bfd-8ede86f9b093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sitzmarks Radiopaque Markers
• Version Model Number: Combo Pak
• Company DUNS: 102463866
• Company Name: KONSYL PHARMACEUTICALS, INC.
• Device Count: 1
• 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	00610858081139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881609

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

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: 2018-07-23
• Device Publish Date: 2018-06-22

On-Brand Devices [Sitzmarks Radiopaque Markers]

• 00610858081306: Combo Pak
• 00610858081139: Combo Pak
• 00610858081122: Tri-Chamber
• 00610858081115: Double D
• 00610858081108: Round Hollow
• 00610858081092: Tri-Chamber
• 00610858081085: Double D
• 00610858081078: Round Hollow
• 00610858081023: Tri-Chamber
• 00610858081016: Double D
• 00610858081009: Round Hollow