NanoCross™ Elite
GUDID 00763000109929
PTA AB14W035040150 NANOCROSS 014 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 | 00763000109929 |
| NIH Device Record Key | 1c472e88-126e-41b5-98af-c63f39438302 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NanoCross™ Elite |
| Version Model Number | AB14W035040150 |
| 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
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 40 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 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 *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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 catheter away from sunlight at room temperature in a dry place. 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 | 00763000109929 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141118
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 | 2 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2018-12-28 |
On-Brand Devices [NanoCross™ Elite]
| 00763000110529 | PTA AB14W060200150 NANOCROSS 014 V05 |
| 00763000110512 | PTA AB14W060200090 NANOCROSS 014 V05 |
| 00763000110505 | PTA AB14W060150150 NANOCROSS 014 V05 |
| 00763000110499 | PTA AB14W060150090 NANOCROSS 014 V05 |
| 00763000110482 | PTA AB14W060120150 NANOCROSS 014 V05 |
| 00763000110475 | PTA AB14W060120090 NANOCROSS 014 V05 |
| 00763000110468 | PTA AB14W060100150 NANOCROSS 014 V05 |
| 00763000110451 | PTA AB14W060100090 NANOCROSS 014 V05 |
| 00763000110444 | PTA AB14W060080150 NANOCROSS 014 V05 |
| 00763000110437 | PTA AB14W060080090 NANOCROSS 014 V05 |
| 00763000110420 | PTA AB14W060060150 NANOCROSS 014 V05 |
| 00763000110413 | PTA AB14W060060090 NANOCROSS 014 V05 |
| 00763000110406 | PTA AB14W060040150 NANOCROSS 014 V05 |
| 00763000110390 | PTA AB14W060040090 NANOCROSS 014 V05 |
| 00763000110383 | PTA AB14W060020150 NANOCROSS 014 V05 |
| 00763000110376 | PTA AB14W060020090 NANOCROSS 014 V05 |
| 00763000110369 | PTA AB14W050200150 NANOCROSS 014 V05 |
| 00763000110352 | PTA AB14W050200090 NANOCROSS 014 V05 |
| 00763000110345 | PTA AB14W050150150 NANOCROSS 014 V05 |
| 00763000110338 | PTA AB14W050150090 NANOCROSS 014 V05 |
| 00763000110321 | PTA AB14W050120150 NANOCROSS 014 V05 |
| 00763000110314 | PTA AB14W050120090 NANOCROSS 014 V05 |
| 00763000110307 | PTA AB14W050100150 NANOCROSS 014 V05 |
| 00763000110291 | PTA AB14W050100090 NANOCROSS 014 V05 |
| 00763000110284 | PTA AB14W050080150 NANOCROSS 014 V05 |
| 00763000110277 | PTA AB14W050080090 NANOCROSS 014 V05 |
| 00763000110260 | PTA AB14W050060150 NANOCROSS 014 V05 |
| 00763000110253 | PTA AB14W050060090 NANOCROSS 014 V05 |
| 00763000110246 | PTA AB14W050040150 NANOCROSS 014 V05 |
| 00763000110239 | PTA AB14W050040090 NANOCROSS 014 V05 |
| 00763000110222 | PTA AB14W050020150 NANOCROSS 014 V05 |
| 00763000110215 | PTA AB14W050020090 NANOCROSS 014 V05 |
| 00763000110208 | PTA AB14W040210150 NANOCROSS 014 V05 |
| 00763000110192 | PTA AB14W040210090 NANOCROSS 014 V05 |
| 00763000110185 | PTA AB14W040150150 NANOCROSS 014 V05 |
| 00763000110178 | PTA AB14W040150090 NANOCROSS 014 V05 |
| 00763000110161 | PTA AB14W040120150 NANOCROSS 014 V05 |
| 00763000110154 | PTA AB14W040120090 NANOCROSS 014 V05 |
| 00763000110147 | PTA AB14W040100150 NANOCROSS 014 V05 |
| 00763000110130 | PTA AB14W040100090 NANOCROSS 014 V05 |
| 00763000110123 | PTA AB14W040080150 NANOCROSS 014 V05 |
| 00763000110116 | PTA AB14W040080090 NANOCROSS 014 V05 |
| 00763000110109 | PTA AB14W040060150 NANOCROSS 014 V05 |
| 00763000110093 | PTA AB14W040060090 NANOCROSS 014 V05 |
| 00763000110086 | PTA AB14W040040150 NANOCROSS 014 V05 |
| 00763000110079 | PTA AB14W040040090 NANOCROSS 014 V05 |
| 00763000110062 | PTA AB14W040020150 NANOCROSS 014 V05 |
| 00763000110055 | PTA AB14W040020090 NANOCROSS 014 V05 |
| 00763000110048 | PTA AB14W035210150 NANOCROSS 014 V05 |
| 00763000110031 | PTA AB14W035210090 NANOCROSS 014 V05 |
Trademark Results [NanoCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NANOCROSS 86434065 4872926 Live/Registered |
Covidien, LP 2014-10-24 |
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