| 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 |