Theragenics
GUDID 00813787021737
18ga x 20cm Brachytherapy Applicator Needle, Yellow
THERAGENICS CORPORATION
Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle| Primary Device ID | 00813787021737 |
| NIH Device Record Key | 850e5b1b-81e2-40d7-b13b-f339690745a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Theragenics |
| Version Model Number | CPPS-MN-1821-1 |
| 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 | 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 | 00813787021737 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974118
FDA Product Code
| IWJ | System, Applicator, Radionuclide, Manual |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
[00813787021737]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-04 |
| Device Publish Date | 2022-04-26 |
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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