GUDID 08714729005544

Amplatz Type Renal Dilator

BOSTON SCIENTIFIC CORPORATION

Multi-purpose percutaneous drainage catheter

• Primary Device ID: 08714729005544
• NIH Device Record Key: 7583acdb-c55b-456d-8761-06dff78f164b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: M0062601120
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729005544 [Primary]

FDA Product Code

• GCC: Dilator, catheter

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: 2019-07-11
• Device Publish Date: 2016-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00802526618208 - myLUX™ Patient App: 2025-04-21 For Insertable Cardiac Monitor
• 00802526618215 - myLUX™ Patient App: 2025-04-21 for Insertable Cardiac Monitor
• 00191506046330 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046347 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046354 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046361 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046378 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046385 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter