EZDilate - Wire Guided Esophageal/Pyloric/Colonic/Biliary 3-Stage Bal

GUDID 00821925033245

Gyrus Acmi, Inc.

Oesophageal balloon catheter Oesophageal balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter Intrauterine haemostatic balloon catheter

• Primary Device ID: 00821925033245
• NIH Device Record Key: 75b3be9f-ee3a-45ff-8fd2-b50fa18ba0e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZDilate - Wire Guided Esophageal/Pyloric/Colonic/Biliary 3-Stage Bal
• Version Model Number: BD-410X-1355
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925033245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143609

FDA Product Code

• KNQ: Dilator, esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04

On-Brand Devices [EZDilate - Wire Guided Esophageal/Pyloric/Colonic/Biliary 3-Stage Bal]

• 00821925033276: BD-410X-2055
• 00821925033269: BD-410X-1855
• 00821925033252: BD-410X-1555
• 00821925033245: BD-410X-1355
• 00821925033238: BD-410X-1055
• 00821925033221: BD-410X-0855