| Primary Device ID | 00850645007472 |
| NIH Device Record Key | 51d0bcc9-fd8d-4644-8bc0-0c7172202693 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AOS Prostate Template, Syed/Neblett/Hedger |
| Version Model Number | TPD0001-017 |
| Company DUNS | 060398989 |
| Company Name | ALPHA-OMEGA SERVICES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850645007472 [Primary] |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
[00850645007472]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-04 |
| 00850645007472 | Template, Syed/Neblett/Hedger, Series-17, Prostate, (18 Holes), Blue, 1 ea |
| 00850645007465 | Template, Syed/Neblett/Hedger, Series-15, Prostate, (18 Holes), Yellow, 1 ea |