Home GUDID 00840185300553 4CIS SARA SPINE SYSTEM
Primary DI 00840185300553
Brand 4CIS SARA SPINE SYSTEM
Company SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model AISP-1012-6540
Catalog number 1012-6540
Device description Poly-axial Pedicle Screw, Ø6.5 mm , 40 mm Length
Published 2021-03-26
Public version status Update
Distribution status Not 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 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 00840185300553 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 00840185300553 00840185300553 840185300553 0840185300553
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 868354728 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840185300560 4CIS SARA SPINE SYSTEM AISP-1012-6545 1012-6545 2021-03-26 00840185300577 4CIS SARA SPINE SYSTEM AISP-1012-6550 1012-6550 2021-03-26 00840185300584 4CIS SARA SPINE SYSTEM AISP-1012-6555 1012-6555 2021-03-26 00840185327352 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0214 0105-0214 2026-05-29 00840185327369 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0134 0105-0134 2026-05-29 00840185327376 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0105 0105-0105 2026-05-29 00840185327383 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0106 0105-0106 2026-05-29 00840185327390 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0107 0105-0107 2026-05-29 00840185327406 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0108 0105-0108 2026-05-29 00840185327413 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0109 0105-0109 2026-05-29 00840185327420 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0110 0105-0110 2026-05-29 00840185327437 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0111 0105-0111 2026-05-29 00840185327444 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0112 0105-0112 2026-05-29 00840185327451 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0123 0105-0123 2026-05-29 00840185327468 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0124 0105-0124 2026-05-29 00840185327475 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0125 0105-0125 2026-05-29 00840185327482 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0126 0105-0126 2026-05-29 00840185327499 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0127 0105-0127 2026-05-29 00840185327505 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0128 0105-0128 2026-05-29 00840185327512 4CIS DOLPHIN TLIF CAGE SYSTEM AIIN-0105-0129 0105-0129 2026-05-29
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