EverFlex
GUDID 00821684068991
STENT PRB35-08-040-080 PROTEGE EF V09
Covidien LP
Multiple peripheral artery stent, bare-metal| Primary Device ID | 00821684068991 |
| NIH Device Record Key | 33745124-2831-46e4-85c6-be92f26ba6b0 |
| Commercial Distribution Discontinuation | 2015-06-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EverFlex |
| Version Model Number | PRB35-08-040-080 |
| 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
Device Dimensions
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
| Catheter Gauge | 6 French |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684068991 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P110023
FDA Product Code
| NIP | STENT, SUPERFICIAL FEMORAL ARTERY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-05-26 |
On-Brand Devices [EverFlex]
| 00821684069615 | STENT PRB35-08-200-120 PROTEGE EF V10 |
| 00821684069608 | STENT PRB35-08-150-120 PROTEGE EF V10 |
| 00821684069592 | STENT PRB35-08-150-080 PROTEGE EF V10 |
| 00821684069585 | STENT PRB35-08-120-120 PROTEGE EF V10 |
| 00821684069578 | STENT PRB35-08-120-080 PROTEGE EF V10 |
| 00821684069561 | STENT PRB35-08-100-120 PROTEGE EF V10 |
| 00821684069554 | STENT PRB35-08-100-080 PROTEGE EF V10 |
| 00821684069547 | STENT PRB35-08-080-120 PROTEGE EF V10 |
| 00821684069530 | STENT PRB35-08-080-080 PROTEGE EF V10 |
| 00821684069523 | STENT PRB35-08-060-120 PROTEGE EF V10 |
| 00821684069516 | STENT PRB35-08-060-080 PROTEGE EF V10 |
| 00821684069509 | STENT PRB35-08-040-120 PROTEGE EF V10 |
| 00821684069493 | STENT PRB35-08-040-080 PROTEGE EF V10 |
| 00821684069486 | STENT PRB35-08-030-120 PROTEGE EF V10 |
| 00821684069479 | STENT PRB35-08-030-080 PROTEGE EF V10 |
| 00821684069462 | STENT PRB35-08-020-120 PROTEGE EF V10 |
| 00821684069455 | STENT PRB35-08-020-080 PROTEGE EF V10 |
| 00821684069448 | STENT PRB35-07-200-120 PROTEGE EF V10 |
| 00821684069431 | STENT PRB35-07-150-120 PROTEGE EF V10 |
| 00821684069424 | STENT PRB35-07-150-080 PROTEGE EF V10 |
| 00821684069417 | STENT PRB35-07-120-120 PROTEGE EF V10 |
| 00821684069400 | STENT PRB35-07-120-080 PROTEGE EF V10 |
| 00821684069394 | STENT PRB35-07-100-120 PROTEGE EF V10 |
| 00821684069387 | STENT PRB35-07-100-080 PROTEGE EF V10 |
| 00821684069370 | STENT PRB35-07-080-120 PROTEGE EF V10 |
| 00821684069363 | STENT PRB35-07-080-080 PROTEGE EF V10 |
| 00821684069356 | STENT PRB35-07-060-120 PROTEGE EF V10 |
| 00821684069349 | STENT PRB35-07-060-080 PROTEGE EF V10 |
| 00821684069332 | STENT PRB35-07-040-120 PROTEGE EF V10 |
| 00821684069325 | STENT PRB35-07-040-080 PROTEGE EF V10 |
| 00821684069318 | STENT PRB35-07-030-120 PROTEGE EF V10 |
| 00821684069301 | STENT PRB35-07-030-080 PROTEGE EF V10 |
| 00821684069295 | STENT PRB35-07-020-120 PROTEGE EF V10 |
| 00821684069288 | STENT PRB35-07-020-080 PROTEGE EF V10 |
| 00821684069271 | STENT PRB35-06-200-120 PROTEGE EF V10 |
| 00821684069264 | STENT PRB35-06-150-120 PROTEGE EF V10 |
| 00821684069257 | STENT PRB35-06-150-080 PROTEGE EF V10 |
| 00821684069240 | STENT PRB35-06-120-120 PROTEGE EF V10 |
| 00821684069233 | STENT PRB35-06-120-080 PROTEGE EF V10 |
| 00821684069226 | STENT PRB35-06-100-120 PROTEGE EF V10 |
| 00821684069219 | STENT PRB35-06-100-080 PROTEGE EF V10 |
| 00821684069202 | STENT PRB35-06-080-120 PROTEGE EF V10 |
| 00821684069196 | STENT PRB35-06-080-080 PROTEGE EF V10 |
| 00821684069189 | STENT PRB35-06-060-120 PROTEGE EF V10 |
| 00821684069172 | STENT PRB35-06-060-080 PROTEGE EF V10 |
| 00821684069165 | STENT PRB35-06-040-120 PROTEGE EF V10 |
| 00821684069158 | STENT PRB35-06-040-080 PROTEGE EF V10 |
| 00821684069141 | STENT PRB35-06-030-120 PROTEGE EF V10 |
| 00821684069134 | STENT PRB35-06-030-080 PROTEGE EF V10 |
| 00821684069127 | STENT PRB35-06-020-120 PROTEGE EF V10 |
Trademark Results [EverFlex]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.