SpiderFX SPD2-US-030-190
GUDID 00821684040485
Embolic Protection Device
Covidien LP
Embolic protection filtering guidewire| Primary Device ID | 00821684040485 |
| NIH Device Record Key | 5354be6b-1c42-4533-afea-fd3d1f16fd9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiderFX |
| Version Model Number | SPD2-US-030-190 |
| Catalog Number | SPD2-US-030-190 |
| 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 |
Device Dimensions
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 0.014 Inch |
| Length | 190 Centimeter |
| Outer Diameter | 3 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684040485 [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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