| Primary Device ID | 20613994346227 |
| NIH Device Record Key | b537cff5-c6c1-47a6-856e-e8635d530798 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MSD WIRE System |
| Version Model Number | 3516 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 10 |
| 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 | 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994346223 [Unit of Use] |
| GS1 | 20613994346227 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20613994346227]
Moist Heat or Steam Sterilization
[20613994346227]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2015-09-29 |
| 20681490717254 | WIRE 3510 DBL SIDED SS DIA 10/10 PK |
| 20673978017826 | WIRE PEARL-TIP 3512 1.2MMX37.5CM |
| 20673978017758 | WIRE 3508 DBL SIDED SS DIA 08/10 PK |
| 20613994346227 | WIRE 3516 DBL SIDED SS DIA 16/10 PK |
| 00721902768675 | CASE 3490078 MSD 3516 WIRE CADDY LID |
| 00721902445910 | CASE 3490076 MSD WIRE 1.2MM CADDY LID |
| 00721902445903 | CASE 3490074 MSD WIRE 1.0MM CADDY LID |
| 00721902445897 | CASE 3490072 MSD WIRE 0.8MM CADDY LID |
| 00721902445866 | CASE 3490040 MSD WIRE INNER TRAY |
| 00613994728487 | CADDY 3490079 MSD WIRE 1.6 MM |
| 00613994728470 | CADDY 3490077 MSD WIRE 1.2 MM |
| 00613994728463 | CADDY 3490075 MSD WIRE 1.0 MM |
| 00763000880712 | WIRE 3510 DBL SIDED SS DIA 10/10 PK |
| 00763000880699 | WIRE 3508 DBL SIDED SS DIA 08/10 PK |
| 00763000880705 | WIRE 3512 DBL SIDED SS DIA 12/10 PK |