OBSIDIO™ M0013972001010

GUDID 00191506039332

Conformable Embolic

BOSTON SCIENTIFIC CORPORATION

Non-neurovascular embolization plug, animal-derived

• Primary Device ID: 00191506039332
• NIH Device Record Key: 12095e0f-5f52-4f6a-be25-e91a1fb6dfcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OBSIDIO™
• Version Model Number: M0013972001010
• Catalog Number: M0013972001010
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00191506039332 [Primary]

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-04
• Device Publish Date: 2023-04-26

On-Brand Devices [OBSIDIO™]

• 00191506039332: Conformable Embolic
• 00191506043124: Conformable Embolic