Primary Device ID | 10840642105094 |
NIH Device Record Key | 00394f48-b355-44f0-9adb-b2b1f4c97b92 |
Commercial Distribution Discontinuation | 2020-04-17 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | CapSure® Spine System |
Version Model Number | 11-3731 |
Catalog Number | 11-3731 |
Company DUNS | 067789763 |
Company Name | Spine Wave, 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 | 203-944-9494 |
GUDID@spinewave.com |
Length | 30 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642105094 [Primary] |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10840642105094]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-04-20 |
Device Publish Date | 2015-10-24 |
10840642104929 | PS2 Screw 5.5mm x 55mm |
10840642104905 | PS2 Screw 5.5mm x 50mm |
10840642104882 | PS2 Screw 5.5mm x 45mm |
10840642104868 | PS2 Screw 5.5mm x 40mm |
10840642104844 | PS2 Screw 5.5mm x 35mm |
10840642104820 | PS2 Screw 5.5mm x 30mm |
10840642104806 | PS2 Screw 5.5mm x 25mm |
10840642105216 | PS2 Screw 7.5mm x 60mm |
10840642105193 | PS2 Screw 7.5mm x 55mm |
10840642105179 | PS2 Screw 7.5mm x 50mm |
10840642105155 | PS2 Screw 7.5mm x 45mm |
10840642105131 | PS2 Screw 7.5mm x 40mm |
10840642105117 | PS2 Screw 7.5mm x 35mm |
10840642105094 | PS2 Screw 7.5mm x 30mm |
10840642105049 | PS2 Screw 6.5mm x 55mm |
10840642105025 | PS2 Screw 6.5mm x 50mm |
10840642105001 | PS2 Screw 6.5mm x 45mm |
10840642104981 | PS2 Screw 6.5mm x 40mm |
10840642104967 | PS2 Screw 6.5mm x 35mm |
10840642104943 | PS2 Screw 6.5mm x 30mm |
10840642129922 | PS3 Tap, 8.0mm, NAV-M |
10840642129915 | PS3 Tap, 7.5mm, NAV-M |
10840642129908 | PS3 Tap, 7.0mm, NAV-M |
10840642129892 | PS3 Tap, 6.5mm, NAV-M |
10840642129885 | PS3 Tap, 6.0mm, NAV-M |
10840642129878 | PS3 Tap, 5.5mm, NAV-M |
10840642129861 | PS3 Tap, 5.0mm, NAV-M |
10840642129854 | PS3 Tap, 4.5mm, NAV-M |
10840642129847 | PS3 Tap, 4.0mm, NAV-M |
10840642129830 | PS3 Screwdriver, NAV-M |
10840642129823 | PS3 Pedicle Probe, Straight, NAV-M |
10840642129816 | PS3 Safety Awl, NAV-M |