U.L.I.S.™
GUDID 03663136016979
Co-Cr Rigid Rod Ø6.0mm x 300mm
SPINEVISION
Bone-screw internal spinal fixation system rod| Primary Device ID | 03663136016979 |
| NIH Device Record Key | 4b5865da-552e-480f-b4f4-098c8a2613fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U.L.I.S.™ |
| Version Model Number | U1 - R630HC |
| Company DUNS | 390377518 |
| Company Name | SPINEVISION |
| 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 |
Device Dimensions
| 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 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663136016979 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133575
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
[03663136016979]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-01-15 |
| Device Publish Date | 2015-10-15 |
On-Brand Devices [U.L.I.S.™]
| 03663136001234 | Reduction screwdriver |
| 03663136028026 | Multi-Axial Reduction Screw ø 8,5 mm L 70 mm |
| 03663136017044 | Co-Cr Rigid Rod Ø6.0mm x 450mm |
| 03663136003788 | MOFALSEBLOC SCREW, Ø 8.5mm, L 85mm |
| 03663136003702 | MOFALSEBLOC SCREW, Ø 8.5mm, L 45mm |
| 03663136003573 | MOFALSEBLOC SCREW, Ø 6.5mm, L 40mm |
| 03663136003443 | MOFALSEBLOC SCREW, Ø 10.5mm, L 90mm |
| 03663136003306 | MULTI-AXIAL SCREW Ø 8.5mm L 85mm |
| 03663136002996 | MULTI-AXIAL SCREW Ø 4.5mm L 35mm |
| 03663136002569 | ROD PERSUADER PLIER |
| 03663136003559 | MOFALSEBLOC SCREW, Ø 5.5mm, L 60mm |
| 03663136003450 | MOFALSEBLOC SCREW, Ø 4.5mm, L 25mm |
| 03663136003191 | MULTI-AXIAL SCREW Ø 7.5mm L 60mm |
| 03663136003153 | MULTI-AXIAL SCREW Ø 7.5mm L 40mm |
| 03663136003078 | MULTI-AXIAL SCREW Ø 5.5mm L 60mm |
| 03663136003047 | MULTI-AXIAL SCREW Ø 5.5mm L 45mm |
| 03663136002965 | MULTI-AXIAL SCREW Ø 10.5mm L 90mm |
| 03663136002873 | MULTI-AXIAL SCREW Ø 10.5mm L 45mm |
| 03663136002705 | MULTI-AXIAL SCREW, DIAMETER 7.5mm, LENGTH 50mm |
| 03663136017099 | Co-Cr Rigid Rod Ø6.0mm x 550mm |
| 03663136003436 | MOFALSEBLOC SCREW, Ø 10.5mm, L 85mm |
| 03663136003429 | MOFALSEBLOC SCREW, Ø 10.5mm, L 80mm |
| 03663136002897 | MULTI-AXIAL SCREW Ø 10.5mm L 55mm |
| 03663136032436 | Multi-Axial Reduction Screw ø 4,5 mm L 30 mm |
| 03663136028200 | Multi-Axial Reduction Screw ø 10,5 mm L 90mm |
| 03663136028064 | Multi-Axial Reduction Screw ø 8,5 mm L 90 mm |
| 03663136027937 | Multi-Axial Reduction Screw ø 7,5 mm L 60 mm |
| 03663136027920 | Multi-Axial Reduction Screw ø 7,5 mm L 55 mm |
| 03663136027845 | Multi-Axial Reduction Screw ø 6,5 mm L 50 mm |
| 03663136027838 | Multi-Axial Reduction Screw ø 6,5 mm L 45 mm |
| 03663136027708 | U.L.I.S. multi-axial reduction screw 4.5mm x 50mm |
| 03663136003610 | MOFALSEBLOC SCREW, Ø 6.5mm, L 60mm |
| 03663136002606 | MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 35mm |
| 03663136032429 | Tab Remover |
| 03663136028231 | Screw removal Instrument |
| 03663136028224 | U.L.I.S.™ Axial Rod Persuader |
| 03663136028217 | Short Rod Template |
| 03663136028194 | Multi-Axial Reduction Screw ø 10,5 mm L 90mm |
| 03663136028187 | Multi-Axial Reduction Screw ø 10,5 mm L 85mm |
| 03663136028170 | Multi-Axial Reduction Screw ø 10,5 mm L 80mm |
| 03663136028163 | Multi-Axial Reduction Screw ø 10,5 mm L 75mm |
| 03663136028156 | Multi-Axial Reduction Screw ø 10,5 mm L 70 mm |
| 03663136028149 | Multi-Axial Reduction Screw ø 10,5 mm L 65 mm |
| 03663136028132 | Multi-Axial Reduction Screw ø 10,5 mm L 60 mm |
| 03663136028125 | Multi-Axial Reduction Screw ø 10,5 mm L 55 mm |
| 03663136028118 | Multi-Axial Reduction Screw ø 10,5 mm L 50 mm |
| 03663136028101 | Multi-Axial Reduction Screw ø 10,5 mm L 45 mm |
| 03663136028095 | Multi-Axial Reduction Screw ø 10,5 mm L 40 mm |
| 03663136028088 | Multi-Axial Reduction Screw ø 10,5 mm L 35 mm |
| 03663136028071 | Multi-Axial Reduction Screw ø 10,5 mm L 30 mm |
Trademark Results [U.L.I.S.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 U.L.I.S. 79092309 4089523 Live/Registered |
Spinevision 2010-12-03 |
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