Primary Device ID | 00613994627698 |
NIH Device Record Key | 3d468f06-5476-49f7-91cd-da85b3b1f05d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | |TSRH® Spinal System |
Version Model Number | 8351523 |
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 | 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 Issuing Agency | Device ID |
---|---|
GS1 | 00613994627698 [Primary] |
MNH | Orthosis, spondylolisthesis spinal fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-06-26 |
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