TheraSphere™ M00139552US1350

GUDID 00191506025434

YTTRIUM-90 GLASS MICROSPHERES

BOSTON SCIENTIFIC CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00191506025434
• NIH Device Record Key: e4b7abff-86e7-4320-9104-75f05bfa6655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSphere™
• Version Model Number: M00139552US1350
• Catalog Number: M00139552US1350
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506025434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200029

FDA Product Code

• NAW: Microspheres radionuclide

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: 2026-03-09
• Device Publish Date: 2026-03-01

On-Brand Devices [TheraSphere™]

• 00191506025625: Administration Accessory Kit
• 00191506025601: Administration set
• 00191506025588: Administration set
• 00191506025564: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025557: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025540: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025533: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025526: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025519: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025502: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025496: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025489: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025472: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025465: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025458: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025441: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025434: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025427: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025410: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025403: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025397: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025380: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025373: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025366: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025359: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025342: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025335: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025328: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025311: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025304: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025298: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025281: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025274: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025267: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025250: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025243: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025236: YTTRIUM-90 GLASS MICROSPHERES
• 00191506025229: YTTRIUM-90 GLASS MICROSPHERES