Home GUDID 00889795120199 Paragon 28 Bone Wedge System
Primary DI 00889795120199
Brand Paragon 28 Bone Wedge System
Company Paragon 28, Inc.
Model AOCWO-16-5
Catalog number AOCWO-16-5
Device description Additive Orthopaedics Organic Cotton Wedge, 16-5
Published 2023-06-26
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 HRS Plate, fixation, bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00889795120199 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 00889795120199 00889795120199 889795120199 0889795120199
GMDN Terms# Term, Definition table Term Definition Metallic osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 042961576 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 false Expiration date on label true 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 00889795155856 APEX 3D Total Ankle Replacement System P11-754-GA01 P11-754-GA01 2026-09-29 00889795155863 APEX 3D Total Ankle Replacement System P11-854-GA01 P11-854-GA01 2026-09-29 00889795155870 APEX 3D Total Ankle Replacement System P11-751-TP12 P11-751-TP12 2026-09-29 00889795155887 APEX 3D Total Ankle Replacement System P11-751-TP34 P11-751-TP34 2026-09-29 00889795155894 APEX 3D Total Ankle Replacement System P11-751-TP56 P11-751-TP56 2026-09-29 00889795135278 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-1 P50-900-AFSL-1 2026-09-24 00889795135285 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-2 P50-900-AFSL-2 2026-09-24 00889795135292 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-3 P50-900-AFSL-3 2026-09-24 00889795135308 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-4 P50-900-AFSL-4 2026-09-24 00889795135315 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-5 P50-900-AFSL-5 2026-09-24 00889795135322 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-6 P50-900-AFSL-6 2026-09-24 00889795135339 Baby Gorilla®/Gorilla® Plating System P50-900-AFSL-7 P50-900-AFSL-7 2026-09-24 00889795120632 Paragon 28 Bone Wedge System AOLEW-22-12 AOLEW-22-12 2023-04-04 00889795118523 Paragon 28 Bone Wedge System AOCW-TRL-16-4.5 AOCW-TRL-16-4.5 2022-10-14 00889795118530 Paragon 28 Bone Wedge System AOCW-TRL-16-5.5 AOCW-TRL-16-5.5 2022-10-14 00889795118547 Paragon 28 Bone Wedge System AOCW-TRL-16-6.5 AOCW-TRL-16-6.5 2022-10-14 00889795118554 Paragon 28 Bone Wedge System AOCW-TRL-18-4.5 AOCW-TRL-18-4.5 2022-10-14 00889795118561 Paragon 28 Bone Wedge System AOCW-TRL-18-5.5 AOCW-TRL-18-5.5 2022-10-14 00889795118578 Paragon 28 Bone Wedge System AOCW-TRL-18-6.5 AOCW-TRL-18-6.5 2022-10-14 00889795118585 Paragon 28 Bone Wedge System AOCW-TRL-20-4.5 AOCW-TRL-20-4.5 2022-10-14
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