Bard® BrachySource® I-125 Implant Seeds in Isosleeve™ Delivery System IS1251
GUDID 00801741078330
BrachySource® I125 SEEDS LOADED IN ISOSLEEVE™ NEEDLES, STERILE
Bard Brachytherapy, Inc.
Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant| Primary Device ID | 00801741078330 |
| NIH Device Record Key | 3bb0563e-fdde-4ec0-b370-cb5fcb387e3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bard® BrachySource® I-125 Implant Seeds in Isosleeve™ Delivery System |
| Version Model Number | IS1251 |
| Catalog Number | IS1251 |
| Company DUNS | 185524860 |
| Company Name | Bard Brachytherapy, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741078330 [Primary] |
| GS1 | 10801741078337 [Package] Package: Other [1 Units] Discontinued: 2021-06-15 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093663
FDA Product Code
| KXK | Source, brachytherapy, radionuclide |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-05 |
Devices Manufactured by Bard Brachytherapy, Inc.
| 10801741078061 - QuickLink™ Cartridge 5.5mm Standard SourceLink™ | 2022-10-31 QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #5 |
| 10801741078078 - QuickLink™ Cartridge 5.5mm Standard SourceLink™ | 2022-10-31 QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #20 |
| 10801741078085 - QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ | 2022-10-31 QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding Spacer Links #5 |
| 10801741078092 - QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ | 2022-10-31 QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding Spacer Links #10 |
| 10801741078108 - QuickLink™ Cartridge 5.0mm Extension SourceLink™ | 2022-10-31 QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Spacer Links #10 |
| 10801741078115 - QuickLink™ Cartridge 5.0mm Extension SourceLink™ | 2022-10-31 QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Spacer Links #20 |
| 10801741078139 - SourceLink™ 5.5mm Standard SourceLink™ | 2022-10-31 SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seeding Spacer Links, 20 ea. |
| 10801741078146 - SourceLink™ 0.5mm Seed-to-Seed SourceLink™ | 2022-10-31 SourceLink™ 0.5mm Seed-to-Seed SourceLink™ - Model 7030205 Synthetic Absorbable Seeding Spacer Links, 5 ea |
Trademark Results [Bard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BARD 97907417 not registered Live/Pending |
XTRM Gears LLC 2023-04-26 |
 BARD 97819147 not registered Live/Pending |
Library of Congress 2023-03-02 |
 BARD 97780614 not registered Live/Pending |
Google LLC 2023-02-03 |
 BARD 97173545 not registered Live/Pending |
Bard College 2021-12-15 |
 BARD 86982669 5476077 Live/Registered |
C. R. Bard, Inc. 2015-05-26 |
 BARD 86593150 4858616 Live/Registered |
C. R. Bard, Inc. 2015-04-10 |
 BARD 85144625 not registered Dead/Abandoned |
Luke Christenson 2010-10-04 |
BARD 85144625 not registered Dead/Abandoned |
Steven Crandall 2010-10-04 |
BARD 85144625 not registered Dead/Abandoned |
Jacob Craner 2010-10-04 |
 BARD 85015955 3873568 Live/Registered |
C. R. Bard, Inc. 2010-04-16 |
 BARD 78296485 not registered Dead/Abandoned |
MATTEL, INC. 2003-09-05 |
 BARD 76070857 not registered Dead/Abandoned |
Tvornica duhana Rovinj 2000-06-14 |
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