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 |
00763000663865 - n/a | 2025-07-28 DRILL BIT 7080513 STERILE 13MM |
00763000856472 - Pyramesh® Implant System | 2025-07-28 MESH 905-412 PYRM 10 X 14 OVOID X 12MM |
00763000856489 - Pyramesh® Implant System | 2025-07-28 MESH 905-415 PYRM 10 X 14 OVOID X 15MM |
00763000856502 - Pyramesh® Implant System | 2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM |
00763000856519 - Pyramesh® Implant System | 2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM |
00763000856526 - Pyramesh® Implant System | 2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM |
00763000856533 - Pyramesh® Implant System | 2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM |
00763000856557 - Pyramesh® Implant System | 2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM |