SOLAR Anorectal Manometry Catheter

GUDID 10627825014837

SOLAR Anorectal Manometry Catheter

Laborie Medical Technologies Corp.

Gastrointestinal motility manometric catheter, electronic

• Primary Device ID: 10627825014837
• NIH Device Record Key: 8cd57b8d-6250-4933-bb56-399de850d7f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLAR Anorectal Manometry Catheter
• Version Model Number: K1210AC-L-2212
• Company DUNS: 117783313
• Company Name: Laborie Medical Technologies Corp.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627825014830 [Primary]
GS1	10627825014837 [Package]; Contains: 00627825014830; Package: [5 Units]; In Commercial Distribution
GS1	20627825014834 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234107

FDA Product Code

• KLA: Monitor, Esophageal Motility, Anorectal Motility, And Tube

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: 2025-03-14
• Device Publish Date: 2025-03-06

Devices Manufactured by Laborie Medical Technologies Corp.

• 00627825014823 - SOLAR Anorectal Manometry Charger: 2025-03-14 SOLAR Anorectal Manometry Charger
• 10627825014837 - SOLAR Anorectal Manometry Catheter: 2025-03-14SOLAR Anorectal Manometry Catheter
• 10627825014837 - SOLAR Anorectal Manometry Catheter: 2025-03-14 SOLAR Anorectal Manometry Catheter
• 08720648846052 - SOLAR Compact: 2025-03-14 SOLAR Compact
• 08720648846069 - PIM NXT for eSense: 2025-03-03
• 00627825013529 - e•Sense 7Fr Single Sensor Bladder Catheter: 2024-12-20 e•Sense 7Fr Single Sensor Bladder Catheter
• 10627825013533 - e•Sense 7Fr Single Sensor Coudé Bladder Catheter: 2024-12-20 e•Sense 7Fr Single Sensor Coudé Bladder Catheter
• 10627825013540 - e•Sense 7Fr Dual Sensor Urethral Catheter: 2024-12-20 e•Sense 7Fr Dual Sensor Urethral Catheter
• 00627825013550 - e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter: 2024-12-20 e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter