DxTerity™ TRA
GUDID 20643169738724
CATH U6TRAN35 DXT 6F 5PK 100CM TRN35
MEDTRONIC, INC.
Angiographic catheter, single-use| Primary Device ID | 20643169738724 |
| NIH Device Record Key | 8f5cee8a-5d2e-4352-b1ac-f0da9bd2e234 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DxTerity™ TRA |
| Version Model Number | U6TRAN35 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | false |
| 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 | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169738720 [Primary] |
| GS1 | 20643169738724 [Package] Contains: 00643169738720 Package: PK [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161287
FDA Product Code
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-06 |
On-Brand Devices [DxTerity™ TRA]
| 20643169739141 | CATH U6TRACTSHA DXT 6F 5PK 110CM TRACT |
| 20643169739134 | CATH U5TRACTSHA DXT 5F 5PK 110CM TRACT |
| 20643169739110 | CATH U6TRACTSH DXT 6F 5PK 100CM TRACT |
| 20643169739103 | CATH U5TRACTSH DXT 5F 5PK 100CM TRACT |
| 20643169739080 | CATH U6TRACT DXT 6F 5PK 100CM TRACT |
| 20643169739073 | CATH U5TRACT DXT 5F 5PK 100CM TRACT |
| 20643169739059 | CATH U6TRACKSHA DXT 6F 5PK 110CM TRACK |
| 20643169739042 | CATH U5TRACKSHA DXT 5F 5PK 110CM TRACK |
| 20643169739028 | CATH U6TRACKSH DXT 6F 5PK 100CM TRACK |
| 20643169739011 | CATH U5TRACKSH DXT 5F 5PK 100CM TRACK |
| 20643169738991 | CATH U6TRACK DXT 6F 5PK 100CM TRACK |
| 20643169738984 | CATH U5TRACK DXT 5F 5PK 100CM TRACK |
| 20643169738960 | CATH U6TRAN45SHA DXT 6F 5PK 110CM TRN45 |
| 20643169738953 | CATH U5TRAN45SHA DXT 5F 5PK 110CM TRN45 |
| 20643169738939 | CATH U6TRAN45SH DXT 6F 5PK 100CM TRN45 |
| 20643169738922 | CATH U5TRAN45SH DXT 5F 5PK 100CM TRN45 |
| 20643169738908 | CATH U6TRAN45 DXT 6F 5PK 100CM TRN45 |
| 20643169738892 | CATH U5TRAN45 DXT 5F 5PK 100CM TRN45 |
| 20643169738878 | CATH U6TRAN40SHA DXT 6F 5PK 110CM TRN40 |
| 20643169738861 | CATH U5TRAN40SHA DXT 5F 5PK 110CM TRN40 |
| 20643169738847 | CATH U6TRAN40SH DXT 6F 5PK 100CM TRN40 |
| 20643169738830 | CATH U5TRAN40SH DXT 5F 5PK 100CM TRN40 |
| 20643169738816 | CATH U6TRAN40 DXT 6F 5PK 100CM TRN40 |
| 20643169738809 | CATH U5TRAN40 DXT 5F 5PK 100CM TRN40 |
| 20643169738786 | CATH U6TRAN35SHA DXT 6F 5PK 110CM TRN35 |
| 20643169738779 | CATH U5TRAN35SHA DXT 5F 5PK 110CM TRN35 |
| 20643169738755 | CATH U6TRAN35SH DXT 6F 5PK 100CM TRN35 |
| 20643169738748 | CATH U5TRAN35SH DXT 5F 5PK 100CM TRN35 |
| 20643169738724 | CATH U6TRAN35 DXT 6F 5PK 100CM TRN35 |
| 20643169738717 | CATH U5TRAN35 DXT 5F 5PK 100CM TRN35 |
| 20643169738694 | CATH U6TRAP45SHA DXT 6F 5PK 110CM TRP45 |
| 20643169738687 | CATH U5TRAP45SHA DXT 5F 5PK 110CM TRP45 |
| 20643169738663 | CATH U6TRAP45SH DXT 6F 5PK 100CM TRP45 |
| 20643169738656 | CATH U5TRAP45SH DXT 5F 5PK 100CM TRP45 |
| 20643169738632 | CATH U6TRAP45 DXT 6F 5PK 100CM TRP45 |
| 20643169738625 | CATH U5TRAP45 DXT 5F 5PK 100CM TRP45 |
| 20643169738601 | CATH U6TRAP40SHA DXT 6F 5PK 110CM TRP40 |
| 20643169738595 | CATH U5TRAP40SHA DXT 5F 5PK 110CM TRP40 |
| 20643169738571 | CATH U6TRAP40SH DXT 6F 5PK 100CM TRP40 |
| 20643169738564 | CATH U5TRAP40SH DXT 5F 5PK 100CM TRP40 |
| 20643169738540 | CATH U6TRAP40 DXT 6F 5PK 100CM TRP40 |
| 20643169738533 | CATH U5TRAP40 DXT 5F 5PK 100CM TRP40 |
| 20643169738519 | CATH U6TRAP35SHA DXT 6F 5PK 110CM TRP35 |
| 20643169738502 | CATH U5TRAP35SHA DXT 5F 5PK 110CM TRP35 |
| 20643169738489 | CATH U6TRAP35SH DXT 6F 5PK 100CM TRP35 |
| 20643169738472 | CATH U5TRAP35SH DXT 5F 5PK 100CM TRP35 |
| 20643169738458 | CATH U6TRAP35 DXT 6F 5PK 100CM TRP35 |
| 20643169738441 | CATH U5TRAP35 DXT 5F 5PK 100CM TRP35 |
| 20763000016887 | CATH U6ULTRA45SHA DXT 6F 5PK 110CM UL45 |
| 20763000016870 | CATH U5ULTRA45SHA DXT 5F 5PK 110CM UL45 |
Trademark Results [DxTerity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DXTERITY 88324666 not registered Live/Pending |
27 Software U.S., Inc. 2019-03-04 |
 DXTERITY 87350066 not registered Dead/Abandoned |
DxTerity Diagnostics, Inc. 2017-02-26 |
 DXTERITY 87350060 5630340 Live/Registered |
DxTerity Diagnostics, Inc. 2017-02-26 |
 DXTERITY 86415894 5392172 Live/Registered |
Medtronic, Inc. 2014-10-06 |
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