Primary Device ID | M7391613565700 |
NIH Device Record Key | 485a24df-c35a-4c00-9fd7-abc7c937ec23 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TowerLOX EXT Cannulated Polyaxial EXT Screw 6.5 x 70mm |
Version Model Number | 16135-6570 |
Company DUNS | 836975784 |
Company Name | CAPTIVA SPINE, 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 | 5612779480 |
info@captivaspine.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M7391613565700 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M7391613565700]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-08 |
Device Publish Date | 2019-03-29 |
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M73910290070 - TransFasten-LSF, Tissue Dilator | 2024-05-03 Tissue Dilator |
M739102901009 - TransFasten-LSF, Plunger Rod | 2024-05-03 Plunger Rod |
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