Home GUDID 00861445000334 Coronet
Primary DI 00861445000334
Brand Coronet
Company CONEXTIONS MEDICAL INC
Model FA01025
Catalog number FA01025
Device description The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used tofixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissuewasher interconnected via a continuous loop of suture. The implant comes pre-assembled toan inserter, which facilitates concurrent placement of the anchor and soft tissue washer. Adrill bit is provided to allow for the creation of a properly sized pilot hole in the boneimplantation site.
Published 2020-06-30
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name HTN Washer, Bolt Nut HWC Screw, Fixation, Bone JDR Staple, Fixation, Bone KGS Retention Device, Suture MAI Fastener, Fixation, Biodegradable, Soft Tissue MBI Fastener, Fixation, Nondegradable, Soft Tissue
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTN Washer, Bolt Nut Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2 JDR Staple, Fixation, Bone Orthopedic 2 KGS Retention Device, Suture General, Plastic Surgery 1 MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic 2 MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10861445000331 Package GS1 10 In Commercial Distribution 00861445000334 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 10861445000331 10861445000331 00861445000334 00861445000334 861445000334 0861445000334
GMDN Terms# Term, Definition table Term Definition Tendon/ligament bone anchor, non-bioabsorbable A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].
Regulatory Flags# DUNS number 063692935 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00861445000327 CoNextions TR Tendon Repair System-Implant Mechanism FA0004 FA0004 2022-04-28 00861445000303 CoNextions TR Tendon Repair System-Combo Kit FA0001 FA0001 2022-04-28 00861445000310 CoNextions TR Tendon Repair System-Deployment Mechanism FA0002 FA0002 2022-04-28 10861445000300 CoNextions TR Tendon Repair System-Combo Kit FA0001 FA0001 2022-04-28 10861445000317 CoNextions TR Tendon Repair System-Deployment Mechanism FA0002 FA0002 2022-04-28 10861445000324 CoNextions TR Tendon Repair System-Implant Mechanism FA0004 FA0004 2022-04-28 10861445000331 Coronet FA01025 FA01025 2020-06-30
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