Primary Device ID | 10889981096205 |
NIH Device Record Key | de6f1ee2-8c4a-4ed6-a348-298dcafc3200 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spinous Process System |
Version Model Number | 95-3021 |
Catalog Number | 95-3021 |
Company DUNS | 079840876 |
Company Name | SEASPINE ORTHOPEDICS CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
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(760)727-8399 |
custsvcspine@seaspine.com | |
Phone | +1(760)727-8399 |
custsvcspine@seaspine.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10889981096205 [Primary] |
HWN | INSTRUMENT, COMPRESSION |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10889981096205]
Moist Heat or Steam Sterilization
[10889981096205]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-05-21 |
Device Publish Date | 2018-04-18 |
10889981129705 | Plate Inserter, Spinous Process Spacer |
10889981129613 | Spinous Process Implants and Instruments |
10889981120603 | Spinous Process Tray, Caddy |
10889981096281 | 16mm Trial, Spinous Process Spacer |
10889981096274 | 14mm Trial, Spinous Process Spacer |
10889981096267 | 12mm Trial, Spinous Process Spacer |
10889981096250 | 10mm Trial, Spinous Process Spacer |
10889981096243 | 8mm Trial, Spinous Process Spacer |
10889981096236 | 6mm Trial, Spinous Process Spacer |
10889981096205 | Compressor, Spinous Process Spacer |
10889981096199 | Inserter, Spinous Process Spacer |
10889981096175 | Ligament Splitter |
10889981096151 | T15 Driver |
10889981076238 | Spinous Process Spacer, 16mm |
10889981076221 | Spinous Process Spacer, 14mm |
10889981076214 | Spinous Process Spacer, 12mm |
10889981076207 | Spinous Process Spacer, 10mm |
10889981076191 | Spinous Process Spacer, 8mm |
10889981076184 | Spinous Process Spacer, 6mm |