EverCross™
GUDID 00643169974425
PTA AB35W09060080 EVERCROSS 035 V08
Covidien LP
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00643169974425 |
| NIH Device Record Key | 3538e674-ea98-42cf-81ef-0cbbfac5b694 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EverCross™ |
| Version Model Number | AB35W09060080 |
| 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 |
Device Dimensions
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 80 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 *Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light. |
| 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 | 00643169974425 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190753
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-02 |
| Device Publish Date | 2019-11-22 |
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.