CRE™ RX

GUDID 08714729965428

Biliary Balloon Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter, non-medicated

• Primary Device ID: 08714729965428
• NIH Device Record Key: d6a411d4-9411-4e5a-a46b-dc8ce0017b2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRE™ RX
• Version Model Number: M00558870
• 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 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	08714729965428 [Primary]

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

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: 2024-12-23
• Device Publish Date: 2017-10-31

On-Brand Devices [CRE™ RX]

• 08714729965497: Biliary Balloon Dilatation Catheter
• 08714729965480: Biliary Balloon Dilatation Catheter
• 08714729965473: Biliary Balloon Dilatation Catheter
• 08714729965466: Biliary Balloon Dilatation Catheter
• 08714729965459: Biliary Balloon Dilatation Catheter
• 08714729965442: Biliary Balloon Dilatation Catheter
• 08714729965435: Biliary Balloon Dilatation Catheter
• 08714729965428: Biliary Balloon Dilatation Catheter
• 08714729965411: Biliary Balloon Dilatation Catheter