| Primary Device ID | 00763000025694 |
| NIH Device Record Key | 1fc2b97b-c58c-4921-95bf-fc48575dd74c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KYPHON Xpander II Inflatable Bone Tamp |
| Version Model Number | KX103 |
| 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 | false |
| 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 | false |
| 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 (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000025694 [Primary] |
| HXG | TAMP |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2018-12-06 |
| 00763000025731 | BONE TAMP KX203 20/3 XPANDER II IBT |
| 00763000025717 | BONE TAMP KX153 15/3 XPANDER II IBT |
| 00763000025694 | BONE TAMP KX103 10/3 XPANDER II IBT |