Home GUDID 00810068850048 Biocore9 Humeral Resurfacing System
Primary DI 00810068850048
Brand Biocore9 Humeral Resurfacing System
Company Biocore9, LLC
Model Humeral Resurfacing Component 56 mm
Catalog number 02-03-0056
Device description Biocore9 Humeral Head Resurfacing Shoulder Component 56 mm
Published 2021-09-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810068850048 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 00810068850048 00810068850048 810068850048 0810068850048
GMDN Terms# Term, Definition table Term Definition Resurfacing humeral head prosthesis A sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 56 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 5 Degrees Celsius 40 Degrees Celsius Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 093081548 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 00810068850017 Biocore9 Humeral Resurfacing System Humeral Resurfacing Component 44 mm 02-03-0044 2021-09-28 00810068850024 Biocore9 Humeral Resurfacing System Humeral Resurfacing Component 48 mm 02-03-0048 2021-09-28 00810068850031 Biocore9 Humeral Resurfacing System Humeral Resurfacing Component 52 mm 02-03-0052 2021-09-28 00810068850383 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 39.5 mm 01-03-0039 2021-09-27 00810068850390 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 41 mm 01-03-0041 2021-09-27 00810068850406 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 42.5 mm 01-03-0042 2021-09-27 00810068850413 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 44 mm 01-03-0044 2021-09-27 00810068850420 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 45.5 mm 01-03-0045 2021-09-27 00810068850437 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 47 mm 01-03-0047 2021-09-27 00810068850444 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 49 mm 01-03-0049 2021-09-27 00810068850451 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 51 mm 01-03-0051 2021-09-27 00810068850468 Biocore9 Femoral Resurfacing Component Femoral Resurfacing Component - 52.5 mm 01-03-0052 2021-09-27
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