Primary Device ID | 00763000312015 |
NIH Device Record Key | d1fea627-f431-44d4-84e9-765e611875d9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KYPHON® Express™ II Inflatable Bone Tamp |
Version Model Number | KE102 |
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 | |
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 | |
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 | |
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 (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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 | 00763000312015 [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 | 2020-10-05 |
Device Publish Date | 2020-09-25 |
00673978050621 - n/a | 2025-07-25 INSTRUMENT 836-036 HOLT PROBE CURVED |
00199150021543 - Medtronic Reusable Instruments | 2025-07-21 HOLDER X0625020 BONE GRAFT |
00199150021550 - Medtronic Reusable Instruments | 2025-07-21 SLAP HAMMER X0625025 BONE GRAFT HOLDER |
00763000703578 - Medtronic Reusable Instruments | 2025-07-21 CAM SPREADER TRIAL 4000017 6 DEG 17MM |
00763000703592 - Medtronic Reusable Instruments | 2025-07-21 CAM SPREADER TRIAL 4010010 12 DEG 10MM |
00763000703608 - Medtronic Reusable Instruments | 2025-07-21 CAM SPREADER TRIAL 4010011 12 DEG 11MM |
00763000703615 - Medtronic Reusable Instruments | 2025-07-21 CAM SPREADER TRIAL 4010012 12 DEG 12MM |
00763000703622 - Medtronic Reusable Instruments | 2025-07-21 CAM SPREADER TRIAL 4010013 12 DEG 13MM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() KYPHON 77920581 3837842 Dead/Cancelled |
Kyphon SARL 2010-01-26 |
![]() KYPHON 77145293 3380538 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2007-03-30 |
![]() KYPHON 77145286 3380537 Dead/Cancelled |
MEDTRONIC HOLDING COMPANY SARL 2007-03-30 |
![]() KYPHON 76124590 2509449 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2000-09-07 |
![]() KYPHON 75792575 2436526 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 1999-09-03 |