SpiderFX SPD2-US-060-190
GUDID 00821684040515
Embolic Protection Device
Covidien LP
Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire| Primary Device ID | 00821684040515 |
| NIH Device Record Key | 40b64516-edc3-42d3-adc7-f0d77d669393 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiderFX |
| Version Model Number | SPD2-US-060-190 |
| Catalog Number | SPD2-US-060-190 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | true |
| 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 | |
| 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 | |
| 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
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 6 Millimeter |
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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684040515 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063785
FDA Product Code
| NFA | Temporary Coronary Saphenous Vein Bypass Graft for Embolic Protection |
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 | 2015-10-16 |
On-Brand Devices [SpiderFX]
| 00821684040522 | Embolic Protection Device |
| 00821684040515 | Embolic Protection Device |
| 00821684040508 | Embolic Protection Device |
| 00821684040492 | Embolic Protection Device |
| 00821684040485 | Embolic Protection Device |
| 00821684040379 | Embolic Protection Device |
| 00821684040362 | Embolic Protection Device |
| 00821684040355 | Embolic Protection Device |
| 00821684040348 | Embolic Protection Device |
| 00821684040331 | Embolic Protection Device |
Trademark Results [SpiderFX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIDERFX 77166560 3368261 Live/Registered |
COVIDIEN LP 2007-04-26 |
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