Primary Device ID | 00763000557706 |
NIH Device Record Key | 4be42be9-4043-44c6-8d11-43f90c494d94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kyphon® One-Step™ System, Trocar & Diamond and BFD |
Version Model Number | KPX153PB-A |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | true |
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 | 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 | |
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 |
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 | 00763000557706 [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 | 2021-08-17 |
Device Publish Date | 2021-08-09 |
00763000557737 | IBT KIT KPX203PB-A FF X2 20/3 1 STP |
00763000557706 | IBT KIT KPX153PB-A FF X2 15/3 1 STP |
00763000557676 | IBT KIT KPX103PB-A FF X2 10/3 1 STP |
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 |