Primary Device ID | 00643169663251 |
NIH Device Record Key | b3bdf425-d18e-4cb7-abf6-d720d7c61fdb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | T2 STRATOSPHERE™ Expandable Corpectomy System |
Version Model Number | 436025E |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
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 | |
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 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169663251 [Primary] |
MQP | Spinal vertebral body replacement device |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
[00643169663251]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-07-29 |
Device Publish Date | 2019-07-20 |
00643169663190 | CENTERPIECE 436020D 20MM D-SIZE |
00643169663183 | CENTERPIECE 436020C 20MM C-SIZE |
00643169663176 | CENTERPIECE 436020B 20MM B-SIZE |
00643169663169 | CENTERPIECE 436020A 20MM A-SIZE |
00643169611801 | MACHINE SCREW 4369003 3MM SLOTTED |
00763000091255 | TEMPLATE NAV4362530 25MM/30MM TEMPLATE |
00763000091248 | TEMPLATE NAV4362022 20MM/22MM TEMPLATE |
00643169611900 | TEMPLATE NAV4361316 13MM/16MM TEMPLATE |
00643169611894 | INSERTER NAV4360221 20MM/25MM ANGLED |
00643169611870 | INSERTER NAV4360120 20MM/25MM INSERTER |
00643169611863 | INSERTER NAV4360113 13MM INSERTER |
00643169611825 | TEMPLATE NAV4360030 30MM EXTENDED |
00763000168711 | TRAY 4369922 STRATOSPHERE NAV INSTRMENTS |
00643169637405 | LID 4369920 20-25MM CENTERPIECE MODULE |
00643169638518 | TRAY 4369903 LATERAL TEMPLATES-IMPLANTS |
00643169637399 | MODULE 4369919 20-25MM CENTERPIECE |
00643169663145 | CENTERPIECE 436013D 13MM D-SIZE |
00643169709461 | INSERTER 4360221 20MM/25MM ANGLED |
00643169709454 | INSERTER 4360120 20MM/25MM INSERTER |
00643169709447 | INSERTER 4360113 13MM INSERTER |
00643169611795 | MACHINE SCREW 4369002 2MM SLOTTED |
00643169709560 | ENDCAP 436025455 EXTND 25 X 45MM 15 DEG |
00643169709553 | ENDCAP 436025405 EXTND 25 X 40MM 15 DEG |
00643169709546 | ENDCAP 436025355 EXTND 25 X 35MM 15 DEG |
00643169709539 | ENDCAP 436025305 EXTND 25 X 30MM 15 DEG |
00643169709508 | ENDCAP 436020355 EXTND 20 X 35MM 15 DEG |
00643169709492 | ENDCAP 436020305 EXTND 20 X 30MM 15 DEG |
00643169663251 | CENTERPIECE 436025E 25MM E-SIZE |
00643169663244 | CENTERPIECE 436025D 25MM D-SIZE |
00643169663237 | CENTERPIECE 436025C 25MM C-SIZE |
00643169663220 | CENTERPIECE 436025B 25MM B-SIZE |
00643169663213 | CENTERPIECE 436025A 25MM A-SIZE |
00643169663206 | CENTERPIECE 436020E 20MM E-SIZE |
00643169663152 | CENTERPIECE 436013E 13MM E-SIZE |
00643169663138 | CENTERPIECE 436013C 13MM C-SIZE |
00643169663121 | CENTERPIECE 436013B 13MM B-SIZE |
00643169663114 | CENTERPIECE 436013A 13MM A-SIZE |
00643169651104 | ENDCAP 436025450 EXTNDED 25 X 45MM 0 DEG |
00643169651098 | ENDCAP 436025400 EXTNDED 25 X 40MM 0 DEG |
00643169651081 | ENDCAP 436025350 EXTNDED 25 X 35MM 0 DEG |
00643169651074 | ENDCAP 436025300 EXTNDED 25 X 30MM 0 DEG |
00643169651067 | ENDCAP 436020450 EXTNDED 20 X 45MM 0 DEG |
00643169651050 | ENDCAP 436020400 EXTNDED 20 X 40MM 0 DEG |
00643169651043 | ENDCAP 436020350 EXTNDED 20 X 35MM 0 DEG |
00643169651036 | ENDCAP 436020300 EXTNDED 20 X 30MM 0 DEG |
00643169651029 | ENDCAP 4360308 30MM 8 DEGREE |
00643169651012 | ENDCAP 4360305 30MM 15 DEGREE |
00643169651005 | ENDCAP 4360300 30MM 0 DEGREE |
00643169650992 | ENDCAP 4360258 25MM 8 DEGREE |
00643169650985 | ENDCAP 4360255 25MM 15 DEGREE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() T2 STRATOSPHERE 86817545 5546279 Live/Registered |
Warsaw Orthopedic, Inc. 2015-11-12 |