Enteer™
GUDID 00821684073841
GW ENW-SF-014-300 CTO RE-ENTRY V03
Covidien LP
Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual| Primary Device ID | 00821684073841 |
| NIH Device Record Key | ec4f46ea-e214-46ca-a87d-d8c1665e730f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enteer™ |
| Version Model Number | ENW-SF-014-300 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.36 Millimeter |
| Length | 300 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684073841 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120533
FDA Product Code
| PDU | Catheter for crossing total occlusions |
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 | 2016-09-01 |
On-Brand Devices [Enteer™]
| 00821684073841 | GW ENW-SF-014-300 CTO RE-ENTRY V03 |
| 00821684073834 | GW ENW-SD-014-300 CTO RE-ENTRY V03 |
| 00821684073827 | GW ENW-FX-014-300 CTO RE-ENTRY V03 |
| 00821684073797 | CATH ENB-375-20-135 CTO RE-ENTRY V03 |
| 00821684073780 | CATH ENB-275-20-150 CTO RE-ENTRY V03 |
Trademark Results [Enteer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENTEER 87344866 5397871 Live/Registered |
Lin BaoLiu 2017-02-22 |
 ENTEER 85631486 4485816 Live/Registered |
COVIDIEN LP 2012-05-22 |
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