| Primary Device ID | 00850645007137 |
| NIH Device Record Key | fd36ec78-45ad-42fb-a7a8-42736aa1ad90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed |
| Version Model Number | TIB0001-003 |
| Company DUNS | 060398989 |
| Company Name | ALPHA-OMEGA SERVICES, INC. |
| Device Count | 20 |
| 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 | 00850645007137 [Primary] |
| GS1 | 00850645007717 [Unit of Use] |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
Ethylene Oxide
[00850645007137]
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 |
| 00850645007137 | Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Adapt |
| 00850645007120 | Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Adapt |