| Primary Device ID | 10815212026895 |
| NIH Device Record Key | bb02dd7f-42d1-4890-aecb-cd7e320aaf99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoPearl Vertebral Balloon (15mm), 10G |
| Version Model Number | 100.412 |
| Company DUNS | 933506164 |
| Company Name | Izi Medical Products, LLC |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00815212026898 [Primary] |
| GS1 | 10815212026895 [Package] Contains: 00815212026898 Package: [1 Units] In Commercial Distribution |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-13 |
| Device Publish Date | 2024-08-05 |
| 00815212026935 - Duro-Ject Bone Cement Injection Tube | 2024-10-22 |
| 00815212026911 - KIT:BALLOON AND BONE FILLER | 2024-09-05 |
| 00815212026928 - KIT:BALLOON,FILLER,ACCESS,DRILL | 2024-09-05 |
| 10815212026895 - OsteoPearl Vertebral Balloon (15mm), 10G | 2024-08-13 |
| 10815212026895 - OsteoPearl Vertebral Balloon (15mm), 10G | 2024-08-13 |
| 00815212026904 - OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G | 2024-08-13 |
| 00815212024467 - STRYKER NAVIGATED BIOPSY NEEDLE | 2024-08-07 |
| 00815212026874 - BKP-10-12.0-15.0-A | 2024-07-08 |
| 00815212026881 - BKP-11-12.0-15.0-A | 2024-07-08 |