| Primary Device ID | 00643169692046 |
| NIH Device Record Key | c7e6c834-4dc3-411c-96c9-93e72fd13ddb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medtronic Resuable Instruments |
| Version Model Number | X0815073 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169692046 [Primary] |
| HTR | RASP |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
[00643169692046]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-01 |
| Device Publish Date | 2022-07-23 |
| 00613994309266 | POPPER 7971001 SMALL |
| 00613994285133 | TRIAL 9874139 DOUBLE-ENDED 39MM 41MM |
| 00613994285119 | TRIAL 9874143 DOUBLE-ENDED 43MM 45MM |
| 00613994285102 | HOLDER 9874145 STAND ALONE |
| 00613994285096 | PLATE HOLDER 9874640 4 HOLE |
| 00613994284983 | HOLDER 9870001 4HOLE PLATE FREE HAND |
| 00613994284914 | TRIAL 9874135 DOUBLE-ENDED 35MM 37MM |
| 00613994284907 | GUIDE 9874133 DBL BARREL 0 DEG |
| 00613994265579 | TRIAL 9359525 25MM |
| 00613994265562 | TRIAL 9359522 22MM |
| 00613994265555 | TRIAL 9359519 19MM |
| 00613994265548 | TRIAL 9359516 16MM |
| 00613994265531 | TRIAL 9359513 13MM |
| 00673978957814 | INNER TRAY 902-916 ANTERIOR 16MM INST |
| 00673978070001 | CASE 875-947L LID |
| 00673978010076 | CASE 175-947M M CURETTE MODULE |
| 00673978010069 | CASE 175-947 TRAY DC M CURETTES |
| 00673978006192 | CASE 105-121 L-BRACKETS |
| 00673978006017 | CASE 105-102 LID |
| 00643169930186 | RASP X1116036 CURVED |
| 00643169888777 | RASP EX0916019 9MM X 12MM X 16MM |
| 00643169888760 | RASP EX0916018 8MM X 12MM X 16MM |
| 00643169888753 | RASP EX0916017 7MM X 12MM X 16MM |
| 00643169709652 | RASP X0715055 OVAL |
| 00643169692121 | RASP EX0915004 CURVED WITH REVERSE ANGLE |
| 00643169692091 | SHAVER X0815078 15MM W/T HANDLE |
| 00643169692084 | SHAVER X0815077 14MM W/T HANDLE |
| 00643169692077 | SHAVER X0815076 13MM W/T HANDLE |
| 00643169692060 | SHAVER X0815075 12MM W/T HANDLE |
| 00643169692053 | SHAVER X0815074 11MM W/T HANDLE |
| 00643169692046 | SHAVER X0815073 10MM W/T HANDLE |
| 00643169692039 | SHAVER X0815072 9MM W/T HANDLE |
| 00643169692022 | SHAVER X0815071 8MM W/T HANDLE |
| 00643169692015 | SHAVER X0815070 7MM W/T HANDLE |
| 00643169555310 | RASP EX0814164 |
| 00643169349384 | TRAY 9010000576 ISP CORTICAL WEDGE |
| 00613994306265 | DRIVER 8675203 5MM HEX |
| 00613994306227 | DRIVER 8675207 LONG |
| 00763000051372 | DRILL GUIDE EX0817038 20MM |
| 00763000051365 | DRILL GUIDE EX0817037 18MM |
| 00763000051358 | DRILL GUIDE EX0817036 16MM |
| 00763000051341 | DRILL GUIDE EX0817035 14MM |
| 00763000051334 | DRILL GUIDE EX0817034 12MM |
| 00763000015688 | DTS EX0517063 VARIABLE ANGLE |
| 00763000015206 | GUIDE X0517023 ADJSTBLE DPTH VRABLE DRLL |
| 00763000011192 | DTS GUIDE EX0517086 SNGL BARREL VARIABLE |
| 00763000010904 | DRILL GUIDE EX0517006 12MM |
| 00763000010249 | ATTACHMENT X0517005 FLEX ARM |
| 00763000007508 | GUIDE EX0517009 12MM DRILL NARROW |
| 00763000001940 | GUIDE EX0117065 DTS WITH TROCAR TIP |