Wedge MCWED21160
GUDID 00816777025838
Microcatheter
MICROVENTION INC.
Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter| Primary Device ID | 00816777025838 |
| NIH Device Record Key | afc6bf00-f16d-4d4c-bfe9-8ed4db97b701 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wedge |
| Version Model Number | MCWED21160 |
| Catalog Number | MCWED21160 |
| Company DUNS | 003263105 |
| Company Name | MICROVENTION INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| 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 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 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 | 00816777025838 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172014
FDA Product Code
| DQY | Catheter, percutaneous |
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 | 2019-03-21 |
| Device Publish Date | 2018-08-07 |
Devices Manufactured by MICROVENTION INC.
| 00842429117705 - SOFIA 88 | 2023-06-23 SOFIA 88 - 115cm |
| 00842429117743 - Stent | 2023-05-04 LVIS EVO |
| 00842429117750 - Stent | 2023-05-04 LVIS EVO |
| 00842429117767 - Stent | 2023-05-04 LVIS EVO |
| 00842429117774 - Stent | 2023-05-04 LVIS EVO |
| 00842429117781 - Stent | 2023-05-04 LVIS EVO |
| 00842429117798 - Stent | 2023-05-04 LVIS EVO |
| 00842429117804 - Stent | 2023-05-04 LVIS EVO |
Trademark Results [Wedge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WEDGE 98411802 not registered Live/Pending |
OneUp Innovations, Inc. 2024-02-20 |
 WEDGE 98235741 not registered Live/Pending |
Wedge Studio Inc. 2023-10-23 |
 WEDGE 98090121 not registered Live/Pending |
WILLO PRODUCTS COMPANY, LLC 2023-07-18 |
 WEDGE 97565453 not registered Live/Pending |
Road Runner Bike Bags and Accessories, Inc. 2022-08-25 |
 WEDGE 97060167 not registered Live/Pending |
MONTAGUE, Kenneth 2021-10-05 |
 WEDGE 90978313 not registered Live/Pending |
WEDGE FINANCIAL, INC. 2021-05-11 |
 WEDGE 90850566 not registered Live/Pending |
Acorn Engineering Company 2021-07-27 |
 WEDGE 90703003 not registered Live/Pending |
WEDGE FINANCIAL, INC. 2021-05-11 |
 WEDGE 90065033 not registered Live/Pending |
Streamlight, Inc. 2020-07-21 |
 WEDGE 88690751 not registered Live/Pending |
Kwan Kee Industrial Limited 2019-11-13 |
 WEDGE 88367623 not registered Live/Pending |
Noble Security Inc. 2019-04-02 |
 WEDGE 88292722 not registered Live/Pending |
Jeff Weller 2019-02-07 |
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