| Primary Device ID | 00879397003372 |
| NIH Device Record Key | 67972f7f-7592-4ac4-b66d-49a8d18e1cc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Embozene Microspheres (Opaque) |
| Version Model Number | 19020-S0 |
| Company DUNS | 168593429 |
| Company Name | CELONOVA BIOSCIENCES, INC. |
| 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 |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Outer Diameter | 900 Micrometer |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00879397003372 [Primary] |
| NAJ | Agents,Embolic,For Treatment Of Uterine Fibroids |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-07-15 |
| 00879397003419 | Microspheres for Embolization |
| 00879397003402 | Microspheres for Embolization |
| 00879397003396 | Microspheres for Embolization |
| 00879397003389 | Microspheres for Embolization |
| 00879397003372 | Microspheres for Embolization |
| 00879397003365 | Microspheres for Embolization |
| 00879397003358 | Microspheres for Embolization |
| 00879397003341 | Microspheres for Embolization |
| 00879397003334 | Microspheres for Embolization |
| 00879397003327 | Microspheres for Embolization |
| 00879397003310 | Microspheres for Embolization |
| 00879397003303 | Microspheres for Embolization |
| 00879397003297 | Microspheres for Embolization |
| 00879397003280 | Microspheres for Embolization |
| 00879397003273 | Microspheres for Embolization |
| 00879397003266 | Microspheres for Embolization |
| 00879397003259 | Microspheres for Embolization |
| 00879397003242 | Microspheres for Embolization |
| 00879397003235 | Microspheres for Embolization |
| 00879397003228 | Microspheres for Embolization |