Enteer ENW-SD-014-300
GUDID 00821684052761
Guidewire;Standard
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 | 00821684052761 |
| NIH Device Record Key | 977b0051-27b6-470b-b18c-1823ac219e8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enteer |
| Version Model Number | ENW-SD-014-300 |
| Catalog Number | ENW-SD-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 | true |
| 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(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 300 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684052761 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120533
FDA Product Code
| DQX | WIRE, GUIDE, CATHETER |
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 | 2015-10-12 |
On-Brand Devices [Enteer]
| 00821684052778 | Guidewire;Stiff |
| 00821684052761 | Guidewire;Standard |
| 00821684052754 | Guidewire;Flexible |
| 00821684052747 | Re-entry Catheter |
| 00821684052730 | Re-entry Catheter |
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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