| 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 |