| Primary Device ID | 00643169634978 |
| NIH Device Record Key | 42fedb0a-6586-4785-8db7-ad9fbce35f43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2 STRATOSPHERE Expandable Corpectomy System |
| Version Model Number | 4361160 |
| 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 | false |
| 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 |
| Outer Diameter | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169634978 [Primary] |
| MQP | Spinal vertebral body replacement device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-08-24 |
| 00643169709645 | ENDCAP 436125455 EXTND 25X45MM 15 DEG ST |
| 00643169709621 | ENDCAP 436125355 EXTND 25X35MM 15 DEG ST |
| 00643169709614 | ENDCAP 436125305 EXTND 25X30MM 15 DEG ST |
| 00643169709607 | ENDCAP 436120455 EXTND 20X45MM 15 DEG ST |
| 00643169709591 | ENDCAP 436120405 EXTND 20X40MM 15 DEG ST |
| 00643169709584 | ENDCAP 436120355 EXTND 20X35MM 15 DEG ST |
| 00643169709577 | ENDCAP 436120305 EXTND 20X30MM 15 DEG ST |
| 00643169638464 | ENDCAP 436125450 EXTENDED 25 X 45MM STER |
| 00643169638457 | ENDCAP 436125400 EXTENDED 25 X 40MM STER |
| 00643169638440 | ENDCAP 436125350 EXTENDED 25 X 35MM STER |
| 00643169638433 | ENDCAP 436125300 EXTENDED 25 X 30MM STER |
| 00643169638426 | ENDCAP 436120450 EXTENDED 20 X 45MM STER |
| 00643169638419 | ENDCAP 436120400 EXTENDED 20 X 40MM STER |
| 00643169638402 | ENDCAP 436120350 EXTENDED 20 X 35MM STER |
| 00643169638396 | ENDCAP 436120300 EXTENDED 20 X 30MM STER |
| 00643169635111 | ENDCAP 4361308 30MM 8 DEGREE STERILE |
| 00643169635104 | ENDCAP 4361305 30MM 15 DEGREE STERILE |
| 00643169635098 | ENDCAP 4361300 30MM 0 DEGREE STERILE |
| 00643169635036 | ENDCAP 4361220 22MM 0 DEGREE STERILE |
| 00643169635029 | ENDCAP 4361208 20MM 8 DEGREE STERILE |
| 00643169635012 | ENDCAP 4361205 20MM 15 DEGREE STERILE |
| 00643169635005 | ENDCAP 4361200 20MM 0 DEGREE STERILE |
| 00643169634992 | ENDCAP 4361168 16MM 8 DEGREE STERILE |
| 00643169634879 | CENTERPIECE 436120D 20MM D-SIZE STERILE |
| 00643169634848 | CENTERPIECE 436120A 20MM A-SIZE STERILE |
| 00643169634916 | CENTERPIECE 436125C 25MM C-SIZE STERILE |
| 00643169634855 | CENTERPIECE 436120B 20MM B-SIZE STERILE |
| 00643169634824 | CENTERPIECE 436113D 13MM D-SIZE STERILE |
| 00643169634794 | CENTERPIECE 436113A 13MM A-SIZE STERILE |
| 00643169634930 | CENTERPIECE 436125E 25MM E-SIZE STERILE |
| 00643169634923 | CENTERPIECE 436125D 25MM D-SIZE STERILE |
| 00643169634909 | CENTERPIECE 436125B 25MM B-SIZE STERILE |
| 00643169634893 | CENTERPIECE 436125A 25MM A-SIZE STERILE |
| 00643169634886 | CENTERPIECE 436120E 20MM E-SIZE STERILE |
| 00643169634862 | CENTERPIECE 436120C 20MM C-SIZE STERILE |
| 00643169634831 | CENTERPIECE 436113E 13MM E-SIZE STERILE |
| 00643169634817 | CENTERPIECE 436113C 13MM C-SIZE STERILE |
| 00643169634800 | CENTERPIECE 436113B 13MM B-SIZE STERILE |
| 00643169635081 | ENDCAP 4361258 25MM 8 DEGREE STERILE |
| 00643169635074 | ENDCAP 4361255 25MM 15 DEGREE STERILE |
| 00643169635067 | ENDCAP 4361250 25MM 0 DEGREE STERILE |
| 00643169635050 | ENDCAP 4361228 22MM 8 DEGREE STERILE |
| 00643169635043 | ENDCAP 4361225 22MM 15 DEGREE STERILE |
| 00643169634985 | ENDCAP 4361165 16MM 15 DEGREE STERILE |
| 00643169634978 | ENDCAP 4361160 16MM 0 DEGREE STERILE |
| 00643169634961 | ENDCAP 4361138 13MM 8 DEGREE STERILE |
| 00643169634954 | ENDCAP 4361135 13MM 15 DEGREE STERILE |
| 00643169634947 | ENDCAP 4361130 13MM 0 DEGREE STERILE |
| 00763000864781 | DRIVER 4360420 20/25MM EXPANSION |