NanoCross™ Elite
GUDID 00763000109592
PTA AB14W025040090 NANOCROSS 014 V05
Covidien LP
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00763000109592 |
| NIH Device Record Key | 548c1b6f-a182-4592-8949-f9ee35a2f139 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NanoCross™ Elite |
| Version Model Number | AB14W025040090 |
| 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 | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Catheter Gauge | 4 French |
| Outer Diameter | 2.5 Millimeter |
Operating and Storage Conditions
| 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 *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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000109592 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.