Primary Device ID | B014T4011 |
NIH Device Record Key | b10d20ce-74db-44fa-bd36-e90c9c80f414 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Texas Sidewinder |
Version Model Number | T4011 |
Company DUNS | 022576742 |
Company Name | EMINENT SPINE LLC |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B014T4011 [Primary] |
MQP | Spinal Vertebral Body Replacement Device |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B014T4011]
Moist Heat or Steam Sterilization
[B014T4011]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2017-02-09 |
B014T4016 | T4016 |
B014T4015 | T4015 |
B014T4014 | T4014 |
B014T4013 | T4013 |
B014T4012 | T4012 |
B014T4011 | T4011 |
B014T4010 | T4010 |
B014T4009 | T4009 |
B014T4008 | T4008 |
B014T4007 | T4007 |
B014T3016 | T3016 |
B014T3015 | T3015 |
B014T3014 | T3014 |
B014T3013 | T3013 |
B014T3012 | T3012 |
B014T3011 | T3011 |
B014T3010 | T3010 |
B014T3009 | T3009 |
B014T3008 | T3008 |
B014T3007 | T3007 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TEXAS SIDEWINDER 85094885 4039524 Live/Registered |
Eminent Spine LLC 2010-07-28 |