Home GUDID 00193082162947 ASTRA Spine System
Primary DI 00193082162947
Brand ASTRA Spine System
Company SPINECRAFT, LLC
Model A5R-62C70-325D
Catalog number A5R-62C70-325D
Device description ASTRA Dia. 6.2mm Ti Contoured Rod with Axial Line SL 70 325 mm
Published 2024-04-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ Appliance, fixation, spinal intervertebral body NKB Thoracolumbosacral pedicle screw system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00193082162947 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 00193082162947 00193082162947 193082162947 0193082162947
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 783908713 Device count 1 DM exempt true Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00193082164828 ORIO-3D Cage System 820A-210 820A-210 2026-07-30 00193082167416 ORIO-3D Cage System 820C-210-2 820C-210-2 2026-07-30 00193082167430 ORIO-3D Cage System 820A-200 820A-200 2026-07-30 00193082167447 ORIO-3D Cage System 820A-100 820A-100 2026-07-30 00193082167454 ORIO-3D Cage System 820A-210-1 820A-210-1 2026-07-30 00193082167461 ORIO-3D Cage System 820A-210-2 820A-210-2 2026-07-30 00193082167478 ORIO-3D Cage System 820A-210-3 820A-210-3 2026-07-30 00193082167492 ANTERIS Thoracolumbar Plate System 820A-310 820A-310 2026-07-30 00193082167508 ANTERIS Thoracolumbar Plate System 820A-310-1 820A-310-1 2026-07-30 00193082162084 ANTERIS Thoracolumbar Plate System LPS-APSD-10 LPS-APSD-10 2026-05-20 00193082162091 ANTERIS Thoracolumbar Plate System LPS-APSD-12 LPS-APSD-12 2026-05-20 00193082162107 ANTERIS Thoracolumbar Plate System LPS-APSD-14 LPS-APSD-14 2026-05-20 00193082162114 ANTERIS Thoracolumbar Plate System LPS-APSD-16 LPS-APSD-16 2026-05-20 00193082162121 ANTERIS Thoracolumbar Plate System LPS-APSD-18 LPS-APSD-18 2026-05-20 00193082162138 ANTERIS Thoracolumbar Plate System LPS-APSD-20 LPS-APSD-20 2026-05-20 00193082162145 ANTERIS Thoracolumbar Plate System LPS-APSD-22 LPS-APSD-22 2026-05-20 00193082162152 ANTERIS Thoracolumbar Plate System LPS-APSD-24 LPS-APSD-24 2026-05-20 00193082162169 ANTERIS Thoracolumbar Plate System LPS-APSL-10 LPS-APSL-10 2026-05-20 00193082162176 ANTERIS Thoracolumbar Plate System LPS-APSL-12 LPS-APSL-12 2026-05-20 00193082162183 ANTERIS Thoracolumbar Plate System LPS-APSL-14 LPS-APSL-14 2026-05-20
Other Devices Sharing Product Codes# 
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