| Primary Device ID | 00763000025526 |
| NIH Device Record Key | 6cd760cf-f80a-4daa-9af6-482d5b910a1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KYPHON Bone Biopsy Kit |
| Version Model Number | F18A |
| 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 | 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000025526 [Primary] |
| MJG | DEVICE, PERCUTANEOUS, BIOPSY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-21 |
| Device Publish Date | 2018-12-21 |
| 00763000918033 - Medtronic Reusable Instruments | 2024-04-16 GUIDE EX0923002 UCSS SHORT |
| 00763000918040 - Medtronic Reusable Instruments | 2024-04-16 SCREWDRIVER EX0923003 UCSS FLEX SHORT |
| 00763000918057 - Medtronic Reusable Instruments | 2024-04-16 DRILL BIT EX0923004 UCSS FLEX SHORT |
| 00763000916145 - MSB Reusable Instruments | 2024-04-08 SCREWDRIVER EX0223017 CERVICAL |
| 00763000897024 - Medtronic Reusable Instruments | 2024-04-02 BLADE X07317090 SLIM CC R 90MM |
| 00763000897031 - Medtronic Reusable Instruments | 2024-04-02 BLADE X07317091 SLIM CC L 90MM |
| 00763000897048 - Medtronic Reusable Instruments | 2024-04-02 BLADE X07317092 SLIM LT 90MM |
| 00763000897055 - Medtronic Reusable Instruments | 2024-04-02 BLADE X07317110 SLIM CC R 110MM |