SpiderFX™
GUDID 00821684068366
EP SPD2-US-060-320 SPIDER FX V04
Covidien LP
Embolic protection filtering guidewire| Primary Device ID | 00821684068366 |
| NIH Device Record Key | 2fb88657-24d6-4536-82a9-6e4d9564c896 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiderFX™ |
| Version Model Number | SPD2-US-060-320 |
| 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 | |
| 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 | 320 Centimeter |
| Length | 320 Centimeter |
| Length | 320 Centimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 320 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 |
| 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 | 00821684068366 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| NTE | Temporary Carotid Catheter for Embolic Capture |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-07-23 |
On-Brand Devices [SpiderFX™]
| 00821684068380 | EP SPD2-US-070-320 SPIDER FX V04 |
| 00821684068373 | EP SPD2-US-070-190 SPIDER FX V04 |
| 00821684068366 | EP SPD2-US-060-320 SPIDER FX V04 |
| 00821684068359 | EP SPD2-US-060-190 SPIDER FX V04 |
| 00821684068342 | EP SPD2-US-050-320 SPIDER FX V04 |
| 00821684068335 | EP SPD2-US-050-190 SPIDER FX V04 |
| 00821684068328 | EP SPD2-US-040-320 SPIDER FX V04 |
| 00821684068311 | EP SPD2-US-040-190 SPIDER FX V04 |
| 00821684068304 | EP SPD2-US-030-320 SPIDER FX V04 |
| 00821684068298 | EP SPD2-US-030-190 SPIDER FX V04 |
| 00821684068106 | EP SPD2-US-030-320 SPIDER FX V03 |
Trademark Results [SpiderFX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIDERFX 77166560 3368261 Live/Registered |
COVIDIEN LP 2007-04-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.