EverCross™
GUDID 00821684061299
PTA AB35W04200080 EVERCROSS 035 V05
Covidien LP
Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00821684061299 |
| NIH Device Record Key | 8ace78eb-d65e-4113-bc30-9b3c8cc75984 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EverCross™ |
| Version Model Number | AB35W04200080 |
| 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 |
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 4 Millimeter |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684061299 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103322
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
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 | 2019-08-09 |
| Device Publish Date | 2016-04-24 |
On-Brand Devices [EverCross™]
| 00821684062340 | PTA AB35W12060135 EVERCROSS 035 V05 |
| 00821684062333 | PTA AB35W12060080 EVERCROSS 035 V05 |
| 00821684062326 | PTA AB35W12040135 EVERCROSS 035 V05 |
| 00821684062319 | PTA AB35W12040080 EVERCROSS 035 V05 |
| 00821684062302 | PTA AB35W12020135 EVERCROSS 035 V05 |
| 00821684062296 | PTA AB35W12020080 EVERCROSS 035 V05 |
| 00821684062289 | PTA AB35W10060135 EVERCROSS 035 V05 |
| 00821684062272 | PTA AB35W10060080 EVERCROSS 035 V05 |
| 00821684062265 | PTA AB35W10040135 EVERCROSS 035 V05 |
| 00821684062258 | PTA AB35W10040080 EVERCROSS 035 V05 |
| 00821684062241 | PTA AB35W10030135 EVERCROSS 035 V05 |
| 00821684062234 | PTA AB35W10030080 EVERCROSS 035 V05 |
| 00821684062227 | PTA AB35W10020135 EVERCROSS 035 V05 |
| 00821684062210 | PTA AB35W10020080 EVERCROSS 035 V05 |
| 00821684062203 | PTA AB35W09080135 EVERCROSS 035 V05 |
| 00821684062197 | PTA AB35W09080080 EVERCROSS 035 V05 |
| 00821684062180 | PTA AB35W09060135 EVERCROSS 035 V05 |
| 00821684062173 | PTA AB35W09060080 EVERCROSS 035 V05 |
| 00821684062166 | PTA AB35W09040135 EVERCROSS 035 V05 |
| 00821684062159 | PTA AB35W09040080 EVERCROSS 035 V05 |
| 00821684062142 | PTA AB35W09030135 EVERCROSS 035 V05 |
| 00821684062135 | PTA AB35W09030080 EVERCROSS 035 V05 |
| 00821684062128 | PTA AB35W09020135 EVERCROSS 035 V05 |
| 00821684062111 | PTA AB35W09020080 EVERCROSS 035 V05 |
| 00821684062104 | PTA AB35W08080135 EVERCROSS 035 V05 |
| 00821684062098 | PTA AB35W08080080 EVERCROSS 035 V05 |
| 00821684062081 | PTA AB35W08060135 EVERCROSS 035 V05 |
| 00821684062074 | PTA AB35W08060080 EVERCROSS 035 V05 |
| 00821684062067 | PTA AB35W08060040 EVERCROSS 035 V05 |
| 00821684062050 | PTA AB35W08040135 EVERCROSS 035 V05 |
| 00821684062043 | PTA AB35W08040080 EVERCROSS 035 V05 |
| 00821684062036 | PTA AB35W08040040 EVERCROSS 035 V05 |
| 00821684062029 | PTA AB35W08030135 EVERCROSS 035 V05 |
| 00821684062012 | PTA AB35W08030080 EVERCROSS 035 V05 |
| 00821684062005 | PTA AB35W08020135 EVERCROSS 035 V05 |
| 00821684061992 | PTA AB35W08020080 EVERCROSS 035 V05 |
| 00821684061985 | PTA AB35W08020040 EVERCROSS 035 V05 |
| 00821684061978 | PTA AB35W07200135 EVERCROSS 035 V05 |
| 00821684061961 | PTA AB35W07200080 EVERCROSS 035 V05 |
| 00821684061954 | PTA AB35W07150135 EVERCROSS 035 V05 |
| 00821684061947 | PTA AB35W07150080 EVERCROSS 035 V05 |
| 00821684061930 | PTA AB35W07120135 EVERCROSS 035 V05 |
| 00821684061923 | PTA AB35W07120080 EVERCROSS 035 V05 |
| 00821684061916 | PTA AB35W07100135 EVERCROSS 035 V05 |
| 00821684061909 | PTA AB35W07100080 EVERCROSS 035 V05 |
| 00821684061893 | PTA AB35W07080135 EVERCROSS 035 V05 |
| 00821684061886 | PTA AB35W07080080 EVERCROSS 035 V05 |
| 00821684061879 | PTA AB35W07060135 EVERCROSS 035 V05 |
| 00821684061862 | PTA AB35W07060080 EVERCROSS 035 V05 |
| 00821684061855 | PTA AB35W07060040 EVERCROSS 035 V05 |
Trademark Results [EverCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVERCROSS 88753781 not registered Live/Pending |
Shenzhen Yun Tongda Technology&Service Co., Ltd. 2020-01-10 |
 EVERCROSS 86434070 4862070 Live/Registered |
Covidien, LP 2014-10-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.