Fortrex A35HPV12080080
GUDID 00821684057902
0.035 OTW PTA Balloon Catheter
Covidien LP
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00821684057902 |
| NIH Device Record Key | 5d53aba0-154a-460a-ab00-aa8ec104ec2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortrex |
| Version Model Number | A35HPV12080080 |
| Catalog Number | A35HPV12080080 |
| 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
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 80 Centimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
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 | 00821684057902 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142654
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 | 2015-10-09 |
On-Brand Devices [Fortrex]
| 00821684057919 | 0.035 OTW PTA Balloon Catheter |
| 00821684057902 | 0.035 OTW PTA Balloon Catheter |
| 00821684057896 | 0.035 OTW PTA Balloon Catheter |
| 00821684057889 | 0.035 OTW PTA Balloon Catheter |
| 00821684057872 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057865 | 0.035 OTW PTA Balloon Catheter |
| 00821684057858 | 0.035 OTW PTA Balloon Catheter |
| 00821684057841 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057834 | 0.035 OTW PTA Balloon Catheter |
| 00821684057827 | 0.035 OTW PTA Balloon Catheter |
| 00821684057810 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057803 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057797 | 0.035 OTW PTA Balloon Catheter |
| 00821684057780 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057773 | 0.035 OTW PTA Balloon Catheter |
| 00821684057766 | 0.035 OTW PTA Balloon Catheter |
| 00821684057759 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057742 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057735 | 0.035 OTW PTA Balloon Catheter |
| 00821684057728 | 0.035 OTW PTA Balloon Catheter |
| 00821684057711 | 0.035 OTW PTA Balloon Catheter |
| 00821684057704 | 0.035 OTW PTA Balloon Catheter |
| 00821684057698 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057681 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057674 | 0.035 OTW PTA Balloon Catheter |
| 00821684057667 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057650 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057643 | 0.035 OTW PTA Balloon Catheter |
| 00821684057636 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057629 | 0.035 OTW PTA Balloon Catheter |
| 00821684057612 | 0.035 OTW PTA Balloon Catheter |
| 00821684057605 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057599 | 0.035 OTW PTA Balloon Catheter |
| 00821684057582 | 0.035 OTW PTA Balloon Catheter |
| 00821684057575 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057568 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057551 | 0.035 OTW PTA Balloon Catheter |
| 00821684057544 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057537 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057520 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057513 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057506 | 0.035 OTW PTA Balloon Catheter |
| 00821684057490 | 0.035 OTW PTA Balloon Catheter |
| 00821684057483 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057476 | 0.035 OTW PTA Balloon Catheter |
| 00821684057469 | 0.035 OTW PTA Balloon Catheter |
| 00821684057452 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057445 | 0.035 IN OTW PTA Balloon Catheter |
| 00821684057438 | 0.035 OTW PTA Balloon Catheter |
| 00821684057421 | 0.035 OTW PTA Balloon Catheter |
Trademark Results [Fortrex]
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