TRAcelet™
GUDID 20643169900893
COMPRESSION DEVICE TRACL TRACELET 5PK GL
MEDTRONIC, INC.
Radial artery compression device Radial artery compression device| Primary Device ID | 20643169900893 |
| NIH Device Record Key | ca0d12ba-3406-4507-ad64-ae84be44c388 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRAcelet™ |
| Version Model Number | TRACL |
| 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 | false |
| 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
| Length | 25.2 Centimeter |
| Length | 25.2 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169900899 [Primary] |
| GS1 | 20643169900893 [Package] Contains: 00643169900899 Package: PK [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162027
FDA Product Code
| DXC | CLAMP, VASCULAR |
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 | 2017-01-15 |
On-Brand Devices [TRAcelet™]
| 20643169900909 | COMPRESSION DEVICE TRACR TRACELET 5PK GL |
| 20643169900893 | COMPRESSION DEVICE TRACL TRACELET 5PK GL |
Trademark Results [TRAcelet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACELET 90257814 not registered Live/Pending |
Royal Caribbean Cruises Ltd. 2020-10-15 |
 TRACELET 86213360 5324064 Live/Registered |
Medtronic Vascular, Inc. 2014-03-06 |
 TRACELET 78599920 not registered Dead/Abandoned |
Ramsey, David S. 2005-04-01 |
 TRACELET 77820772 3905290 Dead/Cancelled |
Silverco Inc. 2009-09-04 |
 TRACELET 75276127 not registered Dead/Abandoned |
ADSHEL INC. 1997-04-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.