| Primary Device ID | 10889981029395 |
| NIH Device Record Key | 4a870723-a6ce-4307-9caf-5b267ac7e26c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UCR |
| Version Model Number | 10-1008 |
| Catalog Number | 10-1008 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | 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 | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981029395 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981029395]
Moist Heat or Steam Sterilization
[10889981029395]
Moist Heat or Steam Sterilization
[10889981029395]
Moist Heat or Steam Sterilization
[10889981029395]
Moist Heat or Steam Sterilization
[10889981029395]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
| 10889981119492 | UCR 2 Instrument |
| 10889981082130 | Rod Rotator, 5.5mm Dia |
| 10889981082123 | 5.5 Power Rod Gripper |
| 10889981082109 | Hook Inserter |
| 10889981081072 | Tap 6.0mm, Modular (for 6.5mm Screw) |
| 10889981080402 | COMPRESSOR |
| 10889981080396 | DISTRACTOR |
| 10889981080372 | Reduction THD Driver 5.5/6.75 mm |
| 10889981080365 | 4mm Hex, Large Axial Driver |
| 10889981080358 | 3mm Hex, Large Axial Driver |
| 10889981080341 | 3mm Driver, Small T-Handle |
| 10889981080334 | Static T-Handle, 4mm |
| 10889981080327 | Static T-Handle, 3mm |
| 10889981080310 | CrossBar Limiting Hex Driver |
| 10889981080303 | CROSSBAR HEX DRIVER |
| 10889981080280 | 5.0 mm Trial Rod Silicone Covered |
| 10889981080273 | 5.0 mm Trial Rod Silicone Covered |
| 10889981080266 | Deflection Beam Torque Wrench |
| 10889981080259 | COMBINATION WRENCH 3/16" |
| 10889981080242 | Tabletop Rod Cutter |
| 10889981080235 | LIMITING TORQUE T-HANDLE |
| 10889981080228 | Ratcheting T-Handle |
| 10889981080211 | RATCHETING DRIVER HANDLE |
| 10889981080204 | Rod Cutter |
| 10889981080181 | 20mm Jaw Set Distractor/Compressor (Set of Two) |
| 10889981080174 | Jaw Set 5.5mm - 6.35mm (Set of Two) |
| 10889981080167 | PARALLEL COMPRESSOR WITH INTERCHANGEABLE HNDLS |
| 10889981080150 | PARALLEL DISTRACTOR WITH INTERCHANGEABLE HNDLS |
| 10889981080143 | FRENCH ROD BENDER |
| 10889981080129 | Pedicle Sounder, Straight |
| 10889981080105 | Curved Probe |
| 10889981080099 | Straight Probe |
| 10889981080082 | Bone Awl |
| 10889981080075 | Solid Tap, 8.0mm |
| 10889981080068 | Tap, 8.0mm |
| 10889981080051 | Solid Tap, 6.75mm |
| 10889981080044 | Tap, 7.0mm |
| 10889981080037 | Solid Tap, 5.5mm |
| 10889981080020 | Tap, 5.5mm |
| 10889981080013 | UCR Instrument Tray |
| 10889981080006 | UCR Implant Tray |
| 10889981079994 | 4MM HEX SHAFT |
| 10889981079987 | 3mm Hex Shaft |
| 10889981079956 | Rod Fork |
| 10889981079949 | Rocker |
| 10889981079932 | Simple Tap Sleeve |
| 10889981079925 | X-RAY MARKER, LONG |
| 10889981079918 | X-RAY MARKER, SHORT |
| 10889981079895 | Hex Tip UCR Inserter, 8.0 |
| 10889981079888 | Fixed Tip Inserter Sleeve, 8.0 |