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 |