Home GUDID 00860005968831 RELJA Innovations Nitinol Staple Kit 18x18
Primary DI 00860005968831
Brand RELJA Innovations Nitinol Staple Kit 18x18
Company Relja Innovations LLC
Model RI-NS-18
Device description RELJA Innovations Nitinol Staple Kit 18x18
Published 2025-09-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name JDR Staple, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JDR Staple, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860005968831 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 00860005968831 00860005968831 860005968831 0860005968831
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone staple, non-adjustable A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.
Regulatory Flags# DUNS number 113596350 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860005968824 RELJA Innovations Nitinol Staple Kit 15mmx12mm RI-NS-15 2025-09-19 00860005968848 RELJA Innovations Lapidus Screw Kit RI-LAP-LSK 2026-01-26 00860005968800 MIS Precision Chevron Bunion System RI-2427-C 2022-12-21 00860005968817 RELJA Reduction Clamp (Left and Right) RI-CC-LR RI-CC-LR 2024-01-03
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