Primary Device ID | 00850645007120 |
NIH Device Record Key | 24d470c1-4223-4ceb-b0e7-9bf9ddc12bed |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed |
Version Model Number | TIB0001-002 |
Company DUNS | 060398989 |
Company Name | ALPHA-OMEGA SERVICES, INC. |
Device Count | 10 |
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 | 00850645007120 [Primary] |
GS1 | 00850645007700 [Unit of Use] |
JAQ | System, Applicator, Radionuclide, Remote-Controlled |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
Ethylene Oxide
[00850645007120]
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 |