| Primary Device ID | 00643169703568 |
| NIH Device Record Key | 49640921-ed3d-4cf5-a87b-dde655fc9c6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balloon Kyphoplasty Essentials Kit |
| Version Model Number | NH153PB-CDS |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169703568 [Primary] |
| HRX | ARTHROSCOPE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-25 |
| 00643169703599 | KIT NH152PB-CDS 15/2 SPINE ESSEN FF CDS |
| 00643169703582 | KIT NH102PB-CDS 10/2 SPINE ESSEN FF CDS |
| 00643169703575 | KIT NH203PB-CDS 20/3 SPINE ESSEN FF CDS |
| 00643169703568 | KIT NH153PB-CDS 15/3 SPINE ESSEN FF CDS |
| 00643169703551 | KIT NH103PB-CDS 10/3 SPINE ESSEN FF CDS |
| 00643169703544 | KIT NH152PB 15/2 SPINE ESSEN FF |
| 00643169703537 | KIT NH102PB 10/2 SPINE ESSEN FF |
| 00643169703520 | KIT NH203PB 20/3 SPINE ESSEN FF |
| 00643169703513 | KIT NH153PB 15/3 SPINE ESSEN FF |
| 00643169703506 | KIT NH103PB 10/3 SPINE ESSEN FF |