Theragenics
GUDID 00813787021799
THERAGENICS CORPORATION
Imaging lesion localization marker, implantable| Primary Device ID | 00813787021799 |
| NIH Device Record Key | e3e7328d-d5fc-4d11-adb8-5d969dddf418 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Theragenics |
| Version Model Number | 0705-1 |
| Company DUNS | 114379522 |
| Company Name | THERAGENICS 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 | true |
| 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 | 00813787021799 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071550
FDA Product Code
| KXK | Source, Brachytherapy, Radionuclide |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
[00813787021799]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2020-07-15 |
On-Brand Devices [Theragenics]
| 00813787021782 | 18g 20cm Pre-waxed Brachytherapy Needle, Box of 25 |
| 00813787021775 | 18g 20cm Pre-waxed Brachytherapy Needle, 5 pack |
| 00813787021768 | 18g 20cm Pre-waxed Brachytherapy Needle, 1 pack |
| 00813787021669 | Bio Spacer 910 5.0mm, Nonsterile, QTY 50 |
| 00813787021652 | Bio Spacer 910 5.5mm, Nonsterile, QTY 150 |
| 00813787021638 | XX72xLV |
| 00813787021614 | XX72xiLV |
| 00813787021607 | CPPS-BT-1820-1 |
| 00813787021591 | CPPS-SQ-1820-5 |
| 00813787021584 | CPPS-BT-1820-1 |
| 00813787021577 | CPPS-BT-1820-5 |
| 00813787021560 | CPPS-MN-1825-1 |
| 00813787021553 | CPPS-MN-1825-5 |
| 00813787021546 | CPPS-MN-1720-1 |
| 00813787021539 | CPPS-MN-1720-5 |
| 00813787021522 | CPPS-MN-1820-1 |
| 00813787021515 | CPPS-MN-1820-5 |
| 00813787021508 | CPPS-SQ-1820 |
| 00813787021492 | CPPS-BT-1820 |
| 00813787021485 | CPPS-1720X-1 |
| 00813787021478 | CPPS-1720X-5 |
| 00813787021461 | CPPS-1720X |
| 00813787021454 | 813787021454 |
| 00813787021447 | CPPS-1820X-5 |
| 00813787021430 | CPPS-1820X |
| 00813787021423 | CPPS-SQ-1820X-1 |
| 00813787021416 | CPPS-SQ-1820X-5 |
| 00813787021409 | CPPS-SQ-1820X |
| 00813787021393 | CPPS-MN-1825 |
| 00813787021386 | CPPS-MN-1720 |
| 00813787021379 | CPPS-MN-1820 |
| 00813787021362 | PSS-910-50-50 |
| 00813787021355 | PSS-910-55-20 |
| 00813787021348 | PSS-910-55-50 |
| 00813787021102 | Sterile Loose Gold Markers 1.0mm X 5.0mm (1) |
| 00813787021096 | Gold Fiducial Marker Needles (18g) 1.0mm X 7.0mm (3) |
| 00813787021089 | Gold Fiducial Marker Needles (18g) 1.0mm X 7.0mm (1) |
| 00813787021072 | Gold Fiducial Marker Needles (18g) 1.0mm X 5.0mm (3) |
| 00813787021065 | Gold Fiducial Marker Needles (18g) 1.0mm X 5.0mm (1) |
| 00813787021058 | Gold Fiducial Marker Needles (18g) 1.0mm X 3.0mm (3) |
| 00813787021041 | Gold Fiducial Marker Needles (18g) 1.0mm X 3.0mm (1) |
| 00813787021034 | Gold Fiducial Marker Needles (17g) 1.2mm X 7.0mm (3) |
| 00813787021027 | Gold Fiducial Marker Needles (17g) 1.2mm X 7.0mm (1) |
| 00813787021010 | Gold Fiducial Marker Needles (17g) 1.2mm X 5.0mm (3) |
| 00813787021003 | Gold Fiducial Marker Needles (17g) 1.2mm X 5.0mm (1) |
| 00813787020990 | Gold Fiducial Marker Needles (17g) 1.2mm X 3.0mm (3) |
| 00813787020983 | Gold Fiducial Marker Needles (17g) 1.2mm X 3.0mm (1) |
| 00813787021836 | 0811-1 |
| 00813787021867 | 0811-53 |
| 00813787021850 | 0811-51 |
Trademark Results [Theragenics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERAGENICS 78296116 2943653 Live/Registered |
Theragenics Corporation 2003-09-04 |
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