RIGIFLEX II

GUDID 08714729719120

Single Use Achalasia Ballon Dilator

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 08714729719120
• NIH Device Record Key: 4d96a3a6-814c-4cc2-b404-6993795f6184
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGIFLEX II
• Version Model Number: M00554520
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729719120 [Primary]

FDA Product Code

• PID: esophageal dilator balloon with or without electrode sensors

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: 2020-02-13
• Device Publish Date: 2016-09-24

On-Brand Devices [RIGIFLEX II]

• 08714729719120: Single Use Achalasia Ballon Dilator
• 08714729719113: Single Use Achalasia Ballon Dilator
• 08714729719106: Single Use Achalasia Ballon Dilator