| Primary Device ID | 00763000026806 |
| NIH Device Record Key | 37c6fff0-bb32-4f97-9d5c-b4e6c53bb55a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kyphon V Premium Vertebroplasty |
| Version Model Number | VPT11D |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 00763000026806 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-28 |
| Device Publish Date | 2018-10-28 |
| 00763000026820 | VP BONE ACCESS VPT13D 13GA TROCAR/BEVEL |
| 00763000026813 | BONE ACCESS TOOLS VPT13B 13GA BEVEL |
| 00763000026806 | VP BONE ACCESS VPT11D 11GA TROCAR/BEVEL |
| 00763000026790 | VP BONE ACCESS VPT11B 11GA BEVEL |
| 00763000026776 | TOOLKIT VPT01B VP NEEDLE SET STR 10 GA |
| 00763000026769 | VP 15GA BIOPSY KIT VPB13D W/13GA ACCESS |
| 00763000026752 | VP 15GA BIOPSY VPB13 BIOPSY /TAMP |
| 00763000026745 | VP 13GA BIOPSY KIT VPB11D W/11GA ACCESS |
| 00763000026738 | VP 13GA BIOPSY VPB11 BIOPSY /TAMP |