AnchorMarker
GUDID 00813787021201
4.5mm AnchorMarker, 3-pk
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 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 | 00813787021201 |
| NIH Device Record Key | b85cbb1a-1bac-42ab-adbe-a6aaccbbfa03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AnchorMarker |
| Version Model Number | AM0845SL3-3 |
| Company DUNS | 114379522 |
| Company Name | THERAGENICS CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 00813787021201 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083274
FDA Product Code
| KXK | Source, Brachytherapy, Radionuclide |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
[00813787021201]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-02-02 |
On-Brand Devices [AnchorMarker]
| 00813787021201 | 4.5mm AnchorMarker, 3-pk |
| 00813787021195 | 4.5mm AnchorMarker, 1-pk |
Trademark Results [AnchorMarker]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANCHORMARKER 77799479 3770601 Live/Registered |
THERAGENICS CORPORATION 2009-08-07 |
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