Home GUDID 08800057273844 The JASPER Spinal Fixation System
Primary DI 08800057273844
Brand The JASPER Spinal Fixation System
Company GBS Commonwealth Co.,Ltd.
Model L16A-6334
Published 2019-07-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800057273844 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800057273844 08800057273844 8800057273844
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 694609156 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00880016731781 Prase-C Anterior Cervical Plate System C117-1717 2021-10-31 08800167317827 Prase-C Anterior Cervical Plate System C117-1718 2021-10-31 08800167314369 Prase-C Anterior Cervical Plate System C128-4226 2021-09-30 08800167314376 Prase-C Anterior Cervical Plate System C128-4225 2021-09-30 08800167314383 Prase-C Anterior Cervical Plate System C128-4224 2021-09-30 08800167314390 Prase-C Anterior Cervical Plate System C128-4223 2021-09-30 08800167314406 Prase-C Anterior Cervical Plate System C128-4222 2021-09-30 08800167314413 Prase-C Anterior Cervical Plate System C128-4221 2021-09-30 08800167314420 Prase-C Anterior Cervical Plate System C128-4220 2021-09-30 08800167314437 Prase-C Anterior Cervical Plate System C128-4219 2021-09-30 08800167314444 Prase-C Anterior Cervical Plate System C128-4218 2021-09-30 08800167314451 Prase-C Anterior Cervical Plate System C128-4217 2021-09-30 08800167314468 Prase-C Anterior Cervical Plate System C128-4216 2021-09-30 08800167314475 Prase-C Anterior Cervical Plate System C128-4215 2021-09-30 08800167314482 Prase-C Anterior Cervical Plate System C128-4214 2021-09-30 08800167314499 Prase-C Anterior Cervical Plate System C128-4213 2021-09-30 08800167314505 Prase-C Anterior Cervical Plate System C128-4212 2021-09-30 08800167314512 Prase-C Anterior Cervical Plate System C128-4211 2021-09-30 08800167314529 Prase-C Anterior Cervical Plate System C128-4210 2021-09-30 08800167314536 Prase-C Anterior Cervical Plate System C128-3726 2021-09-30
Other Devices Sharing Product Codes#