| Primary Device ID | 00850645007267 |
| NIH Device Record Key | 3536e94e-3844-4c4c-92b8-85736ef4e7e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AOS Vaginal Guide |
| Version Model Number | GVN1517-007 |
| 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 | 00850645007267 [Primary] |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
[00850645007267]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-05 |
| 00850645007274 | Guide, Vaginal, Series-15, 15 cm, Yellow Set Screw, 1 ea |
| 00850645007267 | Guide, Vaginal, Series-17, 15 cm, Blue Set Screw, 1 ea |
| 00850645007250 | Guide, Vaginal, Series-15, 12 cm, Yellow Set Screw, 1 ea |
| 00850645007243 | Guide, Vaginal, Series-17, 12 cm, Blue Set Screw, 1 ea |