| Primary Device ID | 00850645007335 | 
| NIH Device Record Key | 7dc94e92-32e8-4c40-b502-b2c424508a29 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AOS Flexiguide Needle | 
| Version Model Number | NFV0002-004 | 
| 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 | 00850645007335 [Primary] | 
| GS1 | 00850645007809 [Unit of Use] | 
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
Ethylene Oxide
[00850645007335]
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 | 
| 00850645007366 | Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 25 cm, | 
| 00850645007359 | Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 20 cm, | 
| 00850645007342 | Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 20 cm, | 
| 00850645007335 | Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, | 
| 00850645007328 | Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, | 
| 00850645007311 | Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, | 
| 00850645007298 | Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 25 cm, | 
| 00850645007281 | Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 25 cm, |