EverCross AB35W12020135
GUDID 00821684040096
.035
Covidien LP
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00821684040096 |
| NIH Device Record Key | caa0bbe8-85cf-4b19-9812-4e21c07226be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EverCross |
| Version Model Number | AB35W12020135 |
| Catalog Number | AB35W12020135 |
| 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 | |
| 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 | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Length | 20 Millimeter |
| 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 |
| 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 | 00821684040096 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110319
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 | 2015-10-12 |
On-Brand Devices [EverCross]
| 00821684045992 | .035 |
| 00821684045985 | .035 |
| 00821684045978 | .035 |
| 00821684045961 | .035 |
| 00821684045954 | .035 |
| 00821684045947 | .035 |
| 00821684045930 | .035 |
| 00821684045923 | .035 |
| 00821684045916 | .035 |
| 00821684045909 | .035 |
| 00821684045893 | .035 |
| 00821684045886 | .035 |
| 00821684045879 | .035 |
| 00821684045862 | .035 |
| 00821684045855 | .035 |
| 00821684045848 | .035 |
| 00821684044773 | .035 |
| 00821684044766 | .035 |
| 00821684044759 | .035 |
| 00821684044742 | .035 |
| 00821684044735 | .035 |
| 00821684044728 | .035 |
| 00821684044711 | .035 |
| 00821684044704 | .035 |
| 00821684044698 | .035 |
| 00821684044681 | .035 |
| 00821684044674 | .035 |
| 00821684044667 | .035 |
| 00821684044650 | .035 |
| 00821684044643 | .035 |
| 00821684044636 | .035 |
| 00821684044629 | .035 |
| 00821684040126 | .035 |
| 00821684040119 | .035 |
| 00821684040096 | .035 |
| 00821684040089 | .035 |
| 00821684040072 | .035 |
| 00821684040065 | .035 |
| 00821684040058 | .035 |
| 00821684040041 | .035 |
| 00821684040034 | .035 |
| 00821684040027 | .035 |
| 00821684040010 | .035 |
| 00821684040003 | .035 |
| 00821684039991 | .035 |
| 00821684039984 | .035 |
| 00821684039977 | .035 |
| 00821684039960 | .035 |
| 00821684039953 | .035 |
| 00821684039946 | .035 |
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.