| Primary Device ID | 00850645007441 | 
| NIH Device Record Key | 231fe4a0-1dd0-4815-91fb-748999dcc631 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AOS GYN-3 Template, yed/Neblett/Hedger | 
| Version Model Number | TGD0003-015 | 
| 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 | 00850645007441 [Primary] | 
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
Ethylene Oxide
[00850645007441]
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 | 
| 00850645007113 - AOS Interstitial Templates, Needles, and Accessories | 2024-07-26 COLLAR AND LARGE O-RING WHITE, FOR SERIES-15 & 17 GYN-3 TEMPLATE, DISPOSABLE | 
| 00850645007304 - AOS Interstitial Templates, Needles, and Accessories | 2024-07-26 Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea | 
| 00850645007373 - AOS Interstitial Templates, Needles, and Accesories | 2024-07-26 Guide, Vaginal, Series-15, 12 cm, with Yellow set screw, 1 ea | 
| 00850645007380 - AOS Interstitial Templates, Needles, and Accesories | 2024-07-26 Guide, Vaginal, Series-15, 15 cm, with Yellow set screw, 1 ea | 
| 00850645007571 - AOS Interstitial Templates, Needles, and Accesories | 2024-07-26 Guide, Vaginal, Series-17, 15 cm, with Blue set screw, 1 ea | 
| 00850645007588 - AOS Interstitial Templates, Needles, and Accesories | 2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 10 ea | 
| 00850645007595 - AOS Interstitial Templates, Needles, and Accesories | 2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 15 ea | 
| 00850645007601 - AOS Interstitial Templates, Needles, and Accesories | 2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 20 ea |