AltaTrack AT3DHNW35
GUDID 10884838108582
The AltaTrack 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with an AltaTrack Guidewire and the AltaTrack Equipment.
Philips Medical Systems Nederland B.V.
Luer/Luer linear connector, single-use| Primary Device ID | 10884838108582 |
| NIH Device Record Key | b5879ae6-575b-4c60-9167-ad50844aa2ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AltaTrack |
| Version Model Number | AltaTrack 3D Hub |
| Catalog Number | AT3DHNW35 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 90 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838108585 [Primary] |
| GS1 | 10884838108582 [Package] Contains: 00884838108585 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223918
FDA Product Code
| DQK | Computer, Diagnostic, Programmable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
Devices Manufactured by Philips Medical Systems Nederland B.V.
| 00884838121270 - Philips IntelliSite Pathology Solution | 2024-10-16 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system. |
| 00884838118454 - Philips | 2024-07-26 MRI Needle Block 8G |
| 00884838118461 - Philips | 2024-07-26 Fiducial Marker Sleeve Assembly |
| 00884838118478 - Philips | 2024-07-26 FIDUCIAL MARKER GRID BLOCK ASSEMBLY |
| 00884838118485 - Philips | 2024-07-26 MRI Needle Block 12G |
| 00884838118492 - Philips | 2024-07-26 MRI Needle Block 14G |
| 00884838118508 - Philips | 2024-07-26 MRI Needle Block 16G |
| 00884838118515 - Philips | 2024-07-26 MRI Needle Block 18G |
Trademark Results [AltaTrack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALTATRACK 79175840 5029217 Live/Registered |
Koninklijke Philips N.V. 2015-09-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.