| Primary Device ID | 00813787022253 |
| NIH Device Record Key | 755eb16e-daf1-43a2-b9f2-e513e427b220 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraMark™ |
| Version Model Number | TG4412i |
| Company DUNS | 114379522 |
| Company Name | THERAGENICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00813787022253 [Primary] |
| KXK | Source, Brachytherapy, Radionuclide |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813787022253]
Ethylene Oxide
[00813787022253]
Ethylene Oxide
[00813787022253]
Ethylene Oxide
[00813787022253]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-02 |
| Device Publish Date | 2022-05-25 |
| 00813787022338 | TheraMark (Anchorseed with AgX100 - 5 cm) -STERILE |
| 00813787022321 | TheraMark (Anchorseed with AgX100 - 7 cm) -STERILE |
| 00813787022314 | TheraMark (TheraStrand with AgX100 - 5 cm) - STERILE |
| 00813787022307 | TheraMark (TheraStrand with AgX100 - 7 cm) - STERILE |
| 00813787022291 | TheraMark (AgX100 loose seed - 5 cm ) - STERILE |
| 00813787022284 | TheraMark (AgX100 loose seed - 7 cm ) - STERILE |
| 00813787022277 | TheraMark (TheraStrand with AgX100 -12 cm) - STERILE |
| 00813787022260 | TheraMark (TheraStrand with AgX100 -12 cm) - STERILE |
| 00813787022253 | TheraMark (AgX100 loose seed -12 cm ) - STERILE |