Cios Alpha
GUDID 04056869009032
mobile C-arm
Siemens Healthcare GmbH
Portable general-purpose fluoroscopic x-ray system, digital| Primary Device ID | 04056869009032 |
| NIH Device Record Key | ee991c4b-52e3-4fdf-84e1-6bb4618a7cab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cios Alpha |
| Version Model Number | 10308191 |
| Company DUNS | 313217003 |
| Company Name | Siemens Healthcare GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869009032 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132094
FDA Product Code
| OXO | Image-intensified fluoroscopic x-ray system, mobile |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-03 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Cios Alpha]
| 04056869153490 | mobile C-arm; software version VA30 |
| 04056869009032 | mobile C-arm |
Trademark Results [Cios Alpha]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CIOS ALPHA 79130812 4434545 Live/Registered |
Siemens Healthcare GmbH 2013-02-20 |
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