| Primary Device ID | 00813787021232 |
| NIH Device Record Key | 64974206-0f0d-497f-99c5-3c4ce59fa521 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VariStrand with OncoSeed |
| Version Model Number | ON772xi |
| Company DUNS | 114379522 |
| Company Name | THERAGENICS CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 00813787021232 [Primary] |
| KXK | Source, Brachytherapy, Radionuclide |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813787021232]
Ethylene Oxide
[00813787021232]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-02-10 |
| 00813787022253 - TheraMark™ | 2022-06-02 TheraMark (AgX100 loose seed -12 cm ) - STERILE |
| 00813787022260 - TheraMark™ | 2022-06-02 TheraMark (TheraStrand with AgX100 -12 cm) - STERILE |
| 00813787022277 - TheraMark™ | 2022-06-02 TheraMark (TheraStrand with AgX100 -12 cm) - STERILE |
| 00813787022284 - TheraMark™ | 2022-06-02 TheraMark (AgX100 loose seed - 7 cm ) - STERILE |
| 00813787022291 - TheraMark™ | 2022-06-02 TheraMark (AgX100 loose seed - 5 cm ) - STERILE |
| 00813787022307 - TheraMark™ | 2022-06-02 TheraMark (TheraStrand with AgX100 - 7 cm) - STERILE |
| 00813787022314 - TheraMark™ | 2022-06-02 TheraMark (TheraStrand with AgX100 - 5 cm) - STERILE |
| 00813787022321 - TheraMark™ | 2022-06-02 TheraMark (Anchorseed with AgX100 - 7 cm) -STERILE |