Home GUDID 00810135963008 Caliber Intramedullary Fixation System
Primary DI 00810135963008
Brand Caliber Intramedullary Fixation System
Company NVision Biomedical Technologies, Inc.
Model CLN-50-90
Device description 5.0mm implant 90mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm to 5.0mm in lengths from 50mm to 120mm.
Published 2025-07-21
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 HWC Screw, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810135963008 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 00810135963008 00810135963008 810135963008 0810135963008
GMDN Terms# Term, Definition table Term Definition Clavicle intramedullary nail-like rod A rod intended to be implanted into the intramedullary canal of the clavicle bone for the fixation of a fracture(s) and/or treatment of malunion(s)/nonunion(s). Also referred to as a nail or pin, it may be straight, curved or bendable, and might be partially-threaded, stabilised with a bone screw, and/or incorporate expandable hook-like features for stabilisation; it is typically made of stainless steel. Devices intended to assist with stabilisation (e.g., a bone screw) may be included with the rod. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Outer Diameter 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 047486041 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 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 07901125621176 Versalock Mini and Micro Plating System GM DOS REIS INDUSTRIA E COMERCIO LTDA HWC 2026-09-18 07901125621183 Versalock Mini and Micro Plating System GM DOS REIS INDUSTRIA E COMERCIO LTDA HWC 2026-09-18 07901125621190 Versalock Mini and Micro Plating System GM DOS REIS INDUSTRIA E COMERCIO LTDA HWC 2026-09-18 07901125621206 Versalock Mini and Micro Plating System GM DOS REIS INDUSTRIA E COMERCIO LTDA HWC 2026-09-18 00885556838303 Total Foot System 2 Smith & Nephew, Inc. HWC 2023-04-25 00885556838327 Total Foot System 2 Smith & Nephew, Inc. HWC 2023-04-18 00885556824764 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824771 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824788 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824795 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824818 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824825 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556835043 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835050 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835081 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835098 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835111 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835128 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835135 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835142 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835159 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835173 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836187 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836484 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836163 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836170 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836194 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836200 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836217 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836392 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22
nvisionbiomed.com