Stent FREDX3531
GUDID 00842429114322
FRED-X 27
MICROVENTION INC.
Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent| Primary Device ID | 00842429114322 |
| NIH Device Record Key | 2c39a879-03dc-42c6-b415-881424f38734 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stent |
| Version Model Number | FREDX3531-PMA |
| Catalog Number | FREDX3531 |
| Company DUNS | 003263105 |
| Company Name | MICROVENTION INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842429114322 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P180027
FDA Product Code
| OUT | Intracranial aneurysm flow diverter |
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 | 2022-10-10 |
| Device Publish Date | 2022-04-11 |
On-Brand Devices [Stent]
Trademark Results [Stent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STENT 79230782 not registered Dead/Abandoned |
Air Bag Stopper Holdings Limited 2018-01-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.