| Primary Device ID | 00850645007151 | 
| NIH Device Record Key | 51aab64d-9e2f-4680-a4a0-3a869f4b190f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AOS Implant Tube, Intralumenal | 
| Version Model Number | TII0002-002 | 
| Company DUNS | 060398989 | 
| Company Name | ALPHA-OMEGA SERVICES, INC. | 
| Device Count | 5 | 
| 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 | 00850645007151 [Primary] | 
| GS1 | 00850645007724 [Unit of Use] | 
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
[00850645007151]
Ethylene Oxide
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2019-02-07 | 
| Device Publish Date | 2016-10-05 | 
| 00850645007199 | Implant Tube, Intralumenal, 200 cm, with 5 mm Gold Seed, 1 ea | 
| 00850645007182 | Implant Tube, Intralumenal, 150 cm, with 5 mm Gold Seed, 1 ea | 
| 00850645007175 | Implant Tube, Intralumenal, 100 cm, with 5 mm Gold Seed, 1 ea | 
| 00850645007168 | Implant Tube, Intralumenal, 100 cm, without Gold Seed, 1 ea | 
| 00850645007151 | Implant Tube, Intralumenal, 130 cm Body, 10 cm Draw-Down, Sealed End, Cable Insert, and Gold See | 
| 00850645007144 | Implant Tube, Intralumenal, 130 cm Body, 10 cm Draw-Down, Sealed End, Cable Insert, and Gold See |