Home GUDID 10889981135515 NewPort
Primary DI 10889981135515
Brand NewPort
Company Seaspine Orthopedics Corporation
Model 64-6545
Catalog number 64-6545
Device description NewPort 4mm Hex Screw, Ø6.5 x 45mm
Published 2024-12-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, spondylolisthesis spinal fixation MNI Orthosis, spinal pedicle fixation NKB Thoracolumbosacral pedicle screw system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10889981135515 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10889981135515 10889981135515
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079840876 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10888857598164 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598171 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598188 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598195 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598201 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598218 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598225 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598232 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598249 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-09-17 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-09-17 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 04546540147257 XIA II Stryker Corporation MNI 2014-12-08 04546540147257 XIA II Stryker Corporation MNH 2014-12-08 04546540147257 XIA II Stryker Corporation NKB 2014-12-08 04546540147769 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation NKB 2014-12-08 04546540147769 XIA II Stryker Corporation MNI 2014-12-08
seaspine.com