ADAS 3D
GUDID 08437021722055
ADAS3D MEDICAL S.L.
Surgical simulation system| Primary Device ID | 08437021722055 |
| NIH Device Record Key | 183a294b-c9ce-4705-bd0f-91f408d73fd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADAS 3D |
| Version Model Number | v2.9 |
| Company DUNS | 469095791 |
| Company Name | ADAS3D MEDICAL S.L. |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com | |
| Phone | +17632186473 |
| richard.clark@circlecvi.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437021722055 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210850
FDA Product Code
| LLZ | System, Image Processing, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-17 |
| Device Publish Date | 2022-03-09 |
On-Brand Devices [ADAS 3D]
| 08437021722048 | V2.6 |
| 08437021722031 | V2.8 |
| 08437021722024 | V2.10 |
| 08437021722055 | v2.9 |
| 08437021722086 | V.2.12 |
Trademark Results [ADAS 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADAS 3D 79290357 not registered Live/Pending |
ADAS3D MEDICAL S.L. 2020-06-15 |
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