Home GUDID 00197157081584 ZAVATION SCREW
Primary DI 00197157081584
Brand ZAVATION SCREW
Company Zavation LLC
Model 35035-24
Device description 3500 SERIES POLYAXIAL SCREW, 3.5MM X 24MM
Published 2026-06-04
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 KWP Appliance, Fixation, Spinal Interlaminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00197157081584 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 00197157081584 00197157081584 197157081584 0197157081584
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw (non-sliding) A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 069472800 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 00840466901035 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901493 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901509 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901516 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901523 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901530 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901547 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901554 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901561 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901578 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901585 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901592 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901608 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901615 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901622 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21
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