| Primary Device ID | 00613994761491 |
| NIH Device Record Key | 567c00f7-de9b-4bb9-bae0-411ff123e5d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | na |
| Version Model Number | 5484311 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | |
| 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 | 00613994761491 [Primary] |
| HWN | INSTRUMENT, COMPRESSION |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
[00613994761491]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2021-10-18 |
| 00643169713369 | BIT NAV2076K VRT STERILE DRILL BIT 2.9MM |
| 00643169693838 | DRIVER NAV2024K SOLERA 4.75 STANDARD MAS |
| 00643169545892 | LID NAV2028K LG2NAV TAP MODULE LID |
| 00643169545885 | TAPS MODULE NAV2027K LG2NAV TAPS MODULE |
| 00763000139988 | FORCEPS 9564001 RETRACTOR DOWNWARD |
| 00763000152680 | LID 7068030 1/2 DIN |
| 00763000152673 | TRAY 7068026 OPEN |
| 00763000152666 | TRAY 7068025 EXTENDED |
| 00763000152659 | TRAY 7068027 CAPPED ROD 5.5/6.0 |
| 00763000152642 | TRAY 7068033 ACCESS SYSTEM |
| 00763000152635 | TRAY 7068032 DISTRACTOR DEGEN 5.5/6.0 |
| 00763000152628 | TRAY 7068031 DISTRACTOR DEGEN 4.75 |
| 00763000152611 | MODULE 7068023 EXTENDER TAB |
| 00763000152604 | TRAY 7068022 5.5/6.0 CORE KIT B |
| 00763000152598 | TRAY 7068021 5.5/6.0 CORE KIT A |
| 00613994236098 | AWL 7080911 FIXED ANGLE AWL |
| 00763000140274 | HOLDER 9564008 ENDOSCOPE 18 |
| 00763000140267 | HOLDER 9564006 ENDOSCOPE 16 |
| 00763000140151 | BLADE 9564049 1/4 TUBE S 90MM TI |
| 00763000140144 | BLADE 9564048 1/4 TUBE S 80MM TI |
| 00763000140137 | BLADE 9564047 1/4 TUBE S 70MM TI |
| 00763000140120 | BLADE 9564046 1/4 TUBE S 60MM TI |
| 00763000140113 | BLADE 9564045 1/4 TUBE S 50MM TI |
| 00763000140106 | BLADE 9564044 1/4 TUBE S 40MM TI |
| 00763000140090 | DILATOR 9564040 MICRO SMALL |
| 00763000140083 | BLADE 9564039 1/4 TUBE 90MM TI |
| 00763000140076 | BLADE 9564038 1/4 TUBE 80MM TI |
| 00763000140069 | BLADE 9564037 1/4 TUBE 70MM TI |
| 00763000140052 | BLADE 9564036 1/4 TUBE 60MM TI |
| 00763000140045 | BLADE 9564035 1/4 TUBE 50MM TI |
| 00763000140038 | BLADE 9564034 1/4 TUBE 40MM TI |
| 00763000140021 | DILATOR 9564030 MICRO |
| 00763000140014 | DILATOR 9564010 ONE-STEP |
| 00763000140007 | HOLDER 9564005 BLADE |
| 00763000139995 | KEY 9564002 RETRACTOR |
| 00763000139971 | FORCEPS 9564000 RETRACTOR UPWARD |
| 00673978084169 | INSTRUMENT 950-970 RIB RESECTOR |
| 00673978081540 | RONGUER 906-522 PITUITARY LONG UPBITING |
| 00643169862463 | TAP 3606055 5.0MM |
| 00763000140205 | TEMPLATE 5580154 ROD CURVE 4.75 |
| 00643169789258 | COUNTER TORQUE 6550037 5.5 VOYAGER |
| 00643169785571 | DISTRACTOR 6550007 5.5/6.0 SV COMP/DST A |
| 00613994761491 | TRANSLATOR 5484311 LEFT 4.75 |
| 00763000140168 | SLEEVE 5580150 TYPE A 4.75 |
| 00763000140243 | COUNTERTORQUE 5580163 5.5/6.0 |
| 00763000140199 | COUNTERTORQUE 5580153 4.75 |
| 00643169785588 | DISTRACTOR 6550008 5.5/6.0 SV COMP/DST B |
| 00763000140236 | GUIDE 5580162 INNER 5.5/6.0 |
| 00763000140229 | SLEEVE 5580161 TYPE B 5.5/6.0 |
| 00763000140212 | SLEEVE 5580160 TYPE A 5.5/6.0 |