Scepter XC BC0411XC
GUDID 00810170018565
Balloon Catheter
MICROVENTION INC.
Intravascular occluding balloon catheter, image-guided| Primary Device ID | 00810170018565 |
| NIH Device Record Key | 6f14bf17-5903-43a1-8224-f96971d0338a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scepter XC |
| Version Model Number | BC0411XC-B |
| Catalog Number | BC0411XC |
| Company DUNS | 003263105 |
| Company Name | MICROVENTION INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810170018565 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121785
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 | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Scepter XC]
| 00810170018565 | Balloon Catheter |
| 00810170016370 | Balloon Catheter |
| 00842636020607 | Balloon Catheter |
| 00842636020591 | Balloon Catheter |
Trademark Results [Scepter XC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCEPTER XC 85201023 4305691 Live/Registered |
MicroVention, Inc. 2010-12-17 |
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