SourceLink™ 5.5mm Standard SourceLink™ 7030120
GUDID 10801741078139
SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seeding Spacer Links, 20 ea.
Bard Brachytherapy, Inc.
Brachytherapy source spacer| Primary Device ID | 10801741078139 |
| NIH Device Record Key | aa05e15b-2aab-4f88-ba92-4feedf25d36f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SourceLink™ 5.5mm Standard SourceLink™ |
| Version Model Number | 7030120 |
| Catalog Number | 7030120 |
| Company DUNS | 185524860 |
| Company Name | Bard Brachytherapy, Inc. |
| Device Count | 20 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741078132 [Unit of Use] |
| GS1 | 10801741078139 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023210
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 | 3 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2015-10-05 |
Devices Manufactured by Bard Brachytherapy, Inc.
| 10801741078122 - QuickLink™ | 2024-09-09 QuickLink™ Cartridge 5.5 mm Spacer |
| 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™ | 2022-10-31SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seeding Spacer Links, 20 ea. |
| 10801741078139 - SourceLink™ 5.5mm Standard SourceLink™ | 2022-10-31 SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seeding Spacer Links, 20 ea. |
Trademark Results [SourceLink]
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