Primary Device ID | M739243145350 |
NIH Device Record Key | e487dcc4-0cd9-45fd-a7c5-cc42ab10e464 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MIS Cannulated Polyaxial Screw 4.5 x 35mm |
Version Model Number | 2431-4535 |
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 | 561-277-9480 |
info@captivaspine.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M739243145350 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M739243145350]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-09 |
Device Publish Date | 2020-04-01 |
M739102900109 - TransFasten - LSF, General Instrument Tray | 2024-05-03 Sterilization Case - General Instrument Tray |
M73910290020 - TransFasten - LSF, Quick Connect Drill | 2024-05-03 Quick Connect Drill |
M73910290030 - TransFasten-LSF, Tissue Protector | 2024-05-03 Tissue Protector |
M73910290050 - TransFasten-LSF, Implant Driver Shaft | 2024-05-03 Implant Driver Shaft |
M73910290060 - TransFasten-LSF, Offset Guide | 2024-05-03 Offset Guide |
M73910290070 - TransFasten-LSF, Tissue Dilator | 2024-05-03 Tissue Dilator |
M739102901009 - TransFasten-LSF, Plunger Rod | 2024-05-03 Plunger Rod |
M73910290110 - TransFasten - LSF, Implant Filling Tube | 2024-05-03 Implant Filling Tube |