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

GUDID 00821925033269

Gyrus Acmi, Inc.

Oesophageal balloon catheter

• Primary Device ID: 00821925033269
• NIH Device Record Key: ae2df97d-8fbb-4fe1-a1b4-0fdb2b7b8265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZDilate - Wire Guided Esophageal/Pyloric/Colonic/Biliary 3-Stage Bal
• Version Model Number: BD-410X-1855
• 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	00821925033269 [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