Apex™ Flex

GUDID 08714729475095

PTCA Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 08714729475095
• NIH Device Record Key: 92f4f665-01b4-4f8b-a3b1-11b5840631a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex™ Flex
• Version Model Number: H7493895820150
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729475095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860019

FDA Product Code

• LOX: Catheters, transluminal coronary angioplasty, percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-24

On-Brand Devices [Apex™ Flex]

• 08714729760597: PTCA Dilatation Catheter
• 08714729758464: PTCA Dilatation Catheter
• 08714729475705: PTCA Dilatation Catheter
• 08714729475583: PTCA Dilatation Catheter
• 08714729475354: PTCA Dilatation Catheter
• 08714729475095: PTCA Dilatation Catheter
• 08714729474975: PTCA Dilatation Catheter
• 08714729474746: PTCA Dilatation Catheter