Home GUDID 00844856031463 Novel
Primary DI 00844856031463
Brand Novel
Company ALPHATEC SPINE, INC.
Model 64897-012
Device description SD Cage Trial, Large, 12 mm
Published 2020-03-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ODP Intervertebral fusion device with bone graft, cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00844856031463 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00844856031463 00844856031463 844856031463 0844856031463
GMDN Terms# Term, Definition table Term Definition Spinal implant trial A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 12 Millimeter Length 28 Millimeter Width 9 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 602465783 Device count 1 Lot or batch true 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 00810017915125 SABER-XA, Screw Ø5.0 x 22.5 ELEVATION SPINE, INC. ODP 2026-09-22 00810017915149 SABER-XA, Screw Ø5.0 x 32.5 ELEVATION SPINE, INC. ODP 2026-09-22 00810017915156 SABER-XA, Screw Ø5.5 x 22.5 ELEVATION SPINE, INC. ODP 2026-09-22 00810017915163 SABER-XA, Screw Ø5.5 x 27.5 ELEVATION SPINE, INC. ODP 2026-09-22 07613327503968 Aero-C Stryker Corporation ODP 2019-12-18 10888857461819 CASCADIA™ Interbody System VB Spine LLC ODP 2019-10-31 10888857461888 CASCADIA™ Interbody System VB Spine LLC ODP 2019-10-31 07613327353921 Aero-C Stryker Corporation ODP 2018-06-28 07613327353938 Aero-C Stryker Corporation ODP 2018-06-28 07613327353945 Aero-C Stryker Corporation ODP 2018-06-28 07613327353952 Aero-C Stryker Corporation ODP 2018-06-28 07613327353976 Aero-C Stryker Corporation ODP 2018-06-28 07613327347036 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347050 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347067 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347098 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347159 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347197 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347296 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347333 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347357 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347364 Tritanium C Stryker Corporation ODP 2017-09-18 07613327349535 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360035 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360103 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360257 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360363 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360370 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360516 Tritanium C Stryker Corporation ODP 2017-09-18 07613252602774 AVS Anchor-L Stryker Corporation ODP 2016-09-24
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