| Primary Device ID | 00763000031824 |
| NIH Device Record Key | e209709e-1163-4ed5-b299-c2a0d95402bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KYPHON Express KyphoPak Tray |
| Version Model Number | KPE1003 |
| 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, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000031824 [Primary] |
| HRX | Arthroscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-26 |
| Device Publish Date | 2019-01-26 |
| 00763000031831 | KIT KPE1004 KPHOPAK EXPRESS TRAY 15/2 AF |
| 00763000031824 | KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS |
| 00763000031817 | KIT KPE1002 KYPAK EXPRESS TRAY 10/2 AF |
| 00763000031800 | KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS |