EmboCube™ EC5025
GUDID 10884450306229
BIOSPHERE MEDICAL
Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived| Primary Device ID | 10884450306229 |
| NIH Device Record Key | 912b4835-cab0-4c19-8696-1eb03095e589 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmboCube™ |
| Version Model Number | 00884450306222 |
| Catalog Number | EC5025 |
| Company DUNS | 635091932 |
| Company Name | BIOSPHERE MEDICAL |
| 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 | false |
| OTC Over-The-Counter | false |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450306222 [Primary] |
| GS1 | 10884450306229 [Package] Contains: 00884450306222 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181021
FDA Product Code
| KRD | Device, Vascular, for Promoting Embolization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2019-03-23 |
Devices Manufactured by BIOSPHERE MEDICAL
| 10884450403713 - Embosphere® | 2022-10-10 |
| 10884450403829 - Embosphere® | 2022-10-10 |
| 10884450093662 - Tenor® | 2022-09-30 |
| 10884450299439 - Embosphere® | 2022-09-28 |
| 10884450403058 - Embosphere® | 2019-12-10 |
| 10884450402945 - Embosphere® | 2019-11-08 |
| 10884450403133 - Embosphere® | 2019-09-18 |
| 10884450403423 - Embosphere® | 2019-06-25 |
Trademark Results [EmboCube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMBOCUBE 87222271 5788201 Live/Registered |
Merit Medical Systems, Inc. 2016-11-01 |
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